Medical Infusion Pump Lawsuits
On December 23, 2020, the U.S. Food and Drug Administration released its list of medical device recalls. Most prominent on that list were infusion pumps and their components. These are medical devices that deliver medications directly into the bloodstream in controlled amounts. If they malfunction, they may over- or under-deliver those medications, which can put a person’s health at risk.
The number of Class I infusion pump recalls in 2020 was higher than in previous years, with each recalled pump associated with reports of serious injuries and deaths. The defective medical device lawyers at Chaffin Luhana is currently investigating cases in which patients were seriously injured or killed because of malfunctioning medical pumps.
What Are Infusion Pumps?
Infusion pumps (also called medical pumps) come in a variety of different types, and are used to deliver nutrients or medications such as insulin, hormones, antibiotics, chemotherapy drugs, and pain relievers.
Healthcare professionals use medical pumps in hospitals and nursing homes because they offer greater control over the administration of fluids, and can be programmed to deliver a set amount of medication at a set interval using the built-in software interface.
Patients may also use infusion pumps to administer medications while they go about their daily lives. Software incorporated into the pumps provides a “set it and forget it” option, allowing patients to live normally without having to worry about stopping to inject a medication.
What Are the Different Types of Medical Pumps?
In general, medical pumps can be categorized based on three factors:
- Volume of fluid delivery
Types of Infusion Pumps Based on Mobility
- Stationary Pumps: These are made to remain stationary and to be used with bedridden patients.
- Ambulatory Pumps: These are small and lightweight and are designed to be used while on the go. They provide medication for people with debilitating conditions like type 2 diabetes that help them remain active while still receiving their medication.
Types of Infusion Pumps Based on Function
- Specialty Pumps: These are commonly used in homecare delivery or for conditions like diabetes. They include implantable, enteral, and insulin infusion pumps.
- Traditional Pumps: These are used in medical settings and long-term care settings. They are used to deliver pain medication, antibiotics, chemotherapy medications, and hydrating fluids.
Types of Infusion Pumps Based on Fluid Volume Delivery
- Syringe Pumps: These deliver low levels of medication and are often used on babies and young children.
- Large Volume Pumps: These infuse large volumes of medications or nutrients and are controlled manually or by a computer.
What are the Major Problems of Infusion Pumps?
Most infusion pumps are recalled because of one or more of the following problems:
- Software problems: Something goes wrong with the computer software within the unit. Often an error message is displayed, but not always. Such problems can affect the amount of medication delivered, or may delay or rush delivery.
- Alarm errors: The pump fails to generate the appropriate alarm to alert the user to a critical problem, or generates an alarm when one isn’t required.
- Broken components: One of the components of the pump is broken or damaged, so the pump no longer works as it should. The casing may crack or break, the tubing may be misaligned, or the pump may have been dropped. All of these problems can interfere with the proper infusion of medication.
- Battery failures: A design or manufacturing issue could cause the battery to overheat, leading to premature failure. The low-battery alarm may not be audible, leading to an unexpected shut-down.
- Electric failures: The infusion pump sends out a shock or spark when the user plugs it into an electric outlet, or the pump emits a burning smell or bursts into flames.
- User interface issues: The pump is poorly designed, confuses the user, fails to respond as it should, becomes easily damaged under routine use, or fails to alert the user to problems. The instructions for use may also be unclear.
What Is the Risk of Medical Pumps?
Because many patients rely on infusion pumps to receive the medications they need, infusion pump malfunctions can be extremely serious and even deadly. As far back as 2010, the FDA called for improvements in the design of the devices to reduce the risks associated with them.
In a letter sent to healthcare providers, the administration noted it had seen an increase in the number and severity of infusion pump recalls. Between January 1, 2005, and December 31, 2009, it received over 56,000 medical device reports associated with the use of infusion pumps. Of those, about 1 percent involved deaths, 34 percent involved injuries, and 62 percent involved pump malfunctions.
On April 23, 2010, the FDA announced a new initiative involving three broad actions to address safety problems associated with infusion pumps:
- Establishing additional requirements for infusion pump manufacturers
- Proactively facilitating device improvements
- Increasing user awareness
As part of this initiative, the FDA provided a public workshop on infusion pump design and created a new web page devoted to infusion pump safety. It also required additional safety information from manufacturers and supported ongoing research projects aimed at improving device design.
“These pumps often provide critical fluids to high-risk patients,” said Jeffrey Shuren, M.D., director of the FDA’s Centers for Devices and Radiological Health at the time, “so failures have significant implications.”
On December 13, 2017, the FDA announced that it had been successful in carrying out these actions, adding that it would continue to monitor the performance of the devices moving forward. Despite these attempts to improve infusion pump safety, the devices continue to be associated with problems that put public safety at risk.
List of Infusion Pumps Recalled in 2020
Below is a list of all the infusion pumps that were recalled in 2020.
MiniMed Insulin Pump Recall
On February 12, 2020, the FDA announced a Class 1 recall—the most serious type—of about 322,005 MiniMed 600 Series Insulin Pumps. People with type 1 diabetes used these pumps to deliver insulin.
The affected models were distributed between September 2016 and October 2019 and included:
- Model 630G (MMT-1715)
- Model 670G (MMT-1780)
The retainer ring that helped lock the insulin cartridge into place in the pump’s reservoir compartment could be missing. If the cartridge was not locked firmly into place, the pump could over- or under-deliver insulin, which could cause hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). Severe hyperglycemia may result in a loss of consciousness, seizure, and wrongful death.
Medtronic received 26,421 complaints in which the devices malfunctioned this way. The company was also aware of 2,175 injuries and one death. Medtronic advised customers to examine the retainer ring, and if it was loose, damaged, or missing, to stop using the pump and contact Medtronic for a replacement. If the reservoir locked in place correctly, patients could continue to use it.
Medtronic HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief
On May 28, 2020, the FDA announced a Class 1 Medtronic pump recall for nearly 5,000 components of the HeartWare Ventricular Assist Device (HVAD) System. This device is used in cardiac patients to help the heart deliver blood to the rest of the body.
The outflow graft could tear and the strain relief screw break during assembly before implantation. Surgeons might not notice the damage until during or after attaching the graft to the HVAD pump. Using these affected products could cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures, and death.
At the time of the recall, Medtronic had received 92 complaints related to the pre-implant pump assembly process. The company sent a letter to all affected customers, instructing them to closely inspect the graft after assembly and before implantation for any possible tears and to review the assembly instructions.
Model numbers affected included:
- HVAD Pump Outflow Graft: 1125
- HVAD Pump Implant Kit: 1103
- HVAD Implant Accessories Kit: 1153
The products were distributed between March 1, 2018, and April 1, 2020.
Beckton Dickinson (BD)
Beckton Dickinson implemented five infusion pump recalls in 2020.
Beckton Dickinson (BD) Alaris System Infusion Pumps
The FDA announced the Class 1 recall of about 774,000 Alaris Infusion Pumps on March 6, 2020. The following models were affected:
- BD Alaris System PC Unit Model 8000
- BD Alaris System PC Unit Model 8015
- BD Alaris Pump Module Model 8100
- Alaris Syringe Module Mode 8110
- Alaris PCA Module Model 8120
These products were distributed between 2004 and 2020. They are used in hospitals and other healthcare facilities to deliver fluids, medications, blood, and blood products into a patient’s body in controlled amounts.
BD recalled the devices because of multiple system errors, software errors, and use-related errors that could lead to a delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion).
At the time of the recall, the company was aware of 55 reported injuries and one death related to these issues. BD sent a letter to consumers instructing them to update the software and follow the company’s recommendations to help reduce the risk of errors.
BD Alaris System PC Unit Front Case Keypad Replacement Kits
The FDA announced a second Class 1 recall of 305,526 PC Unit Keypad Replacement Kits on September 14, 2020. The keypads could have one or more unresponsive or stuck keys, which could lead to an infusion delay or prevent healthcare professionals from changing the fluid or medication infusions on the device. The company received 1,186 complaints about this issue and one reported injury.
The affected model was one of the same as in the last recall—the Alaris PC Unit Model 8015. Five keypad replacement kits made for this unit were included in the recall. They were distributed between April 2017 and June 2020.
BD instructed users to follow the cleaning instructions provided with the unit and to remove the unit from service if the keypad had an unresponsive or stuck key and contact the company for a replacement keypad at no charge.
BD Alaris System Infusion Pumps
On September 14, 2020, the FDA announced the recall of over 2.4 million BD Alaris System Infusion Pumps. This time, the models included the following:
- Alaris System PC Unit Model 8000
- Alaris System PC Unit Model 8015
- Alaris Pump Module Model 8100
- Alaris Syringe Module Model 8110
- Alaris PCA Module Model 8120
- Alaris EtCO2 Module Model 8300
- Alaris SpO2 Module Model 8210 and 8220
- Alaris Auto ID Module Model 8600
The company recalled the devices because of several hardware issues, including:
- Situation 1: Damaged Inter-Unit Interface (IUI) Connectors: This problem could lead to interruption of communication of power between PC Unit and modules, which could interrupt therapy.
- Situation 2: Broken elements on Alaris Pump Module platen: A broken upper hinge post, lower hinge, and/or membrane frame on the pump could prevent the device from delivering an accurate amount of fluid, which could result in over- or under-infusion.
- Situation 3: Improperly secured PC unit Barry: If the battery was not properly secured to the unit, the system could experience a power loss.
- Situation 4: Dim Segment: The LED display on the module could have some segments that appeared dim. This could cause user confusion.
BD instructed customers to inspect the devices for these issues and should they be found, to take the devices out of service and contact the company for replacement parts.
BD Alaris Syringe and PCA Modules
Shortly after the previous recall, the FDA announced another Class 1 recall on September 16, 2020. This time, it included nearly 142,000 products distributed between March 2010 and March 2020:
- BD Alaris Syringe Module Model 8110
- BD Alaris PCA Module Model 8120
- BD Alaris Syringe/PCA Sizer Sensor Replacement Kit
These units could display the incorrect syringe types and/or sizes, which could result in infusion delays or over- and under-infusion. The company was aware of no reported injuries.
Customers were advised to check to be sure the infusion pump correctly identified the installed syringe, and if not, to remove it from service and contact the company for a sensor replacement kit.
BD Alaris System Pump Module Door Assembly Replacement Kits
On October 2, 2020, the FDA announced a Class 1 recall of nearly 265,000 Alaris Pump Module Door Assembly Replacement Kits. Affected models included those designed to work with the Alaris Pump Module Model 8100:
The products were manufactured between December 2016 and January 2019. As with the previous recall, the keys on the keypads in these kits could become unresponsive or stuck, affecting the delivery of the fluids. BD received 976 complaints about this issue and told customers to remove the affected pumps from service and “send it to your facility’s biomedical engineering staff” for repair.
CME America, a subsidiary of BD, implemented three infusion pump recalls in 2020.
CME America BodyGuard Microset Infusion Sets
On March 18, 2020, the FDA announced the Class I recall of 91,500 CME America BodyGuard Microset Infusion Sets. These are used with the BodyGuard Infusion Pump System, which is employed in hospital and home-care environments. Products affected included all those with catalog number A120-003XYVA that were distributed between October 2017 and July 2019.
The Microset Infusion Sets, which contained an extended section of tubing longer than the standard lengths, restricted medication flow to the pumping chamber of the infusion pump. This could result in under-infusion, which could cause serious adverse health consequences, including death. The company received three complaints of under-infusion, but no reports of injuries or death.
CME instructed consumers to review the inventory and discard all Microset Infusion Sets and contact the company for further instructions.
CME America BodyGuard Infusion Pump Systems
Just days after the CME America BodyGuard Microset Infusion Sets recall, the FDA announced a second CME Class 1 recall of nearly 28,500 BodyGuard Infusion Pump Systems distributed between March 2009 and November 2019. Model numbers affected included:
- BG 232 Pump
- BodyGuard 121 Twins Pump
- BodyGuard 545 ColorVision Pump
- BodyGuard 575 Pump
- CMExpress Pumps
These infusion pump systems could have a slower-than-expected delivery of medication (under-infusion) and faster than expected delivery (over-infusion). At the time of the recall, the company didn’t know why the units were malfunctioning. It had received 158 complaints regarding this issue, but no reports of injuries or deaths.
Customers were advised to check to see how much fluid was infused and to determine if the devices had been calibrated within the last 12 months. If not, they were to schedule a calibration. The FDA added that customers should notify CME America if the pump was malfunctioning.
CME America Updates Recall of BodyGuard Infusion Pump System
On August 5, 2020, the FDA announced an update to the previous recall, which expanded it to nearly 5 million BodyGuard Infusion Administration Sets. CME America noted at the time that they had received 165 complaints regarding the devices under- or over-delivering infusions.
The company sent a letter to customers on April 27, 2020, informing them that it was removing the BodyGuard Infusion Pumps, accessories, and infusion sets from the market. The letter asked customers to identify and remove any remaining inventory of infusion sets.
On June 16, 2020, CME America sent an updated letter to consumers notifying them of additional testing that showed some sets didn’t meet the delivery accuracy level, which again, meant that the pumps could over- or under-deliver therapies. The company still didn’t know what was causing the problem.
Baxter Healthcare SIGMA Spectrum Infusion Pumps and IQ Infusion Systems
On December 1, 2020, the FDA announced the Class 1 recall of over half a million Baxter Sigma products distributed between July 2008 and July 2020, including:
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Versions 6 & 8)
- Spectrum IQ Infusion System with Dose IQ Safety Software
Baxter Infusion Pumps are used in hospitals and other healthcare facilities and are software-controlled pumps delivering drugs, blood, and blood products.
Improper cleaning could allow residue build-up or corrosion on the device, which could cause an unplanned shutdown without alarming or alerting the user. This could lead to an infusion delay or interruption in treatment. The company was aware of 17,493 complaints about the device and 16 reports of serious injuries.
Baxter Health recommended that customers inspect all pumps and check for residue buildup or corrosion. If it was found, they were to contact Baxter to service the devices.
Smiths Medical Medfusion 3500 and 4000 Syringe Pumps
On February 10, 2021, the FDA announced the Class 1 recall of about 46,395 Smiths Medical Medfusion Syringe Pumps. (The company recalled the devices on June 26, 2020.) The recall affected Model 3500 and 4000 pumps that were distributed between May 2002 and June 2020.
Smiths Medical Medfusion Syringe Pumps are typically used in neonatal and pediatric populations or operating rooms and intensive care units for adults. The company recalled the pumps because of a software error that could lead to over- or under-deliver of fluids. It received four complaints regarding this issue, including one serious injury.
Consumers were told to check the affected pumps to verify the software version and to contact the company for further instructions.
FDA Suggests Patients Take Precautions with Infusion Pumps
Based on the volume of infusion pump recalls, there is evidence that these pumps are still prone to errors, breakdowns, and design issues that can put patient health at risk. The FDA advises patients to take precautions to protect themselves when using an infusion pump. Some of those recommendations include the following:
- Work with your doctors and nurses to create a back-up plan in case of infusion pump failures.
- Know where your infusion pump back-up battery is located and how to access an emergency power supply.
- Learn about your pump and medication.
- Make sure you can read the pump’s display and hear the alarms.
- Verify the settings when starting or changing the rate of medication or fluid. If you have questions, contact your healthcare provider.
Infusion Pump Lawsuits
If you or a loved one was injured because of a malfunctioning infusion pump, you may be eligible to file a personal injury lawsuit to recover damages. Our personal injury attorneys are now investigating these cases and invites you to contact us online or call today at 888-480-1123.