BD Alaris Systems
BD Alaris Systems infusion pumps monitor a patient’s vital signs and deliver medications, blood and fluids into a patient’s body in controlled amounts. Health care facilities and hospitals use these pumps in adults and children.
Becton, Dickinson and Company (BD) manufactures the BD Alaris Systems pumps. The U.S. Food and Drug Administration allowed the first models onto the market in the 1990s. The agency has since cleared more models for sale.
Hospitals and health care facilities across the country use these pumps to deliver nutrients, blood products and medications such as insulin, antibiotics, chemotherapy and pain relievers. Trained users, such as nurses, program these pumps to deliver set quantities of medications and fluids into a patient at specific times.
BD has issued several recalls for these pumps and pump modules because of software and hardware problems that can cause serious injuries and death.
How Do Alaris Pumps Work?
Alaris infusion pumps come with a PCU, or point of care unit, and can be customized with up to four modules. These modules are connected to tubes and bags of medicine or other fluids. The modules work together with the PCU to perform a variety of functions.
BD Alaris PC Unit
The BD Alaris PC Unit or Point of Care Unit (PCU) is the “brain” of the pump system. It has a display and keypad on it. It’s what a trained care professional uses to program the pump with a specific amount of medicine to deliver into a patient, when to deliver it and other specific instructions. Some hospitals or facilities have pre programmed these settings into the PCU.
Modules can be attached to either side of the PCU. These modules perform a variety of tasks from dispensing medication to stopping medication at specific times.
Alaris Syringe Module
The Syringe Module delivers medications, fluids, blood products and blood. The flow of medication is continuous or intermittent.
This module helps ensure accurate medication delivery. It works with various syringe sizes and provides a wide range of flow rates.
BD Pump Module
Health care professionals use the BD Alaris pump module for large volume infusions in pediatric, neonatal or adult patients. Up to four of these modules can attach to the PCU and dispense four different infusions.
Alaris EtCO2 Module
The Alaris EtCO2 Module helps reduce the risk of opioid-induced respiratory depression. It monitors a patient’s respiratory status and stops medicine infusion if the respiratory status falls. Providers can use this module with the PCU or on its own.
Alaris Auto-ID Module
The Auto-ID Module allows providers to scan barcodes that provide information such as the patient ID, clinician ID and drug information. This information goes into the PCU.
Recalled Pumps and Modules
Several recalls of BD Alaris pumps sold in the United States have occurred over the years. The most recent recalls occurred in 2019 and 2020. The recalled models include PCUs, modules and accessories from the 8000 series.
Because these defects may cause serious injuries or death, lawyers are filing BD Alaris Systems lawsuits on behalf of patients injured after using these pumps.
Alaris Pump Model 8100 Infusion Sets
On May 6, 2019, BD recalled 151,139,816 Alaris Pump Model 8100 infusion sets manufactured between May 2016 and March 2019. The pumps could deliver medications too quickly or deliver medications while the pump was not in “running status.”
BD determined that the thickness of silicone segments of the tubing was not uniform. This could cause the tubing to fail or become blocked. The recall was associated with reports of injuries, some of which were serious.
The FDA classified this as a class one recall — the agency’s most severe. This means the devices can cause serious injuries or death.
Alaris Series 8000 PCUs and Modules
On Feb. 4, 2020, BD recalled 774,000 various Alaris series 8000 PCUs and modules. Some of these recalled pumps were distributed as far back as July 2004.
The FDA also classified this as a class one recall.
- Software and system errors
- Alarm failures for low battery and “end of infusion”
- Use-related errors
- Delay options programming
BD said system errors could lead to over or under infusion and interruption of infusion. At the time of the recall, BD was aware of 55 reported injuries and one death.
- Alaris Syringe Module Model 8110, software versions 9.33 and prior, and software version 12.1.0
- Alaris PCA Module Model 8120, software versions 9.33 and prior, and software version 12.1.0
- BD Alaris Pump Module Model 8100, software versions 9.33 and prior, and software version 12.1.0.
- BD Alaris System PC Unit Model 8000, software versions 9.5 and prior
- BD Alaris System PC Unit Model 8015, software versions 9.33 and prior, and software version 12.1.0
BD Alaris System Hardware Recall
On June 20, 2020, BD announced a recall of hardware from its 8000 series pumps.
- Damaged inter-unit interface (IUI) connectors (Situation 1 – Class One)
- Broken elements on module platen (Situation 2 – Class One)
- Improperly secured PCU battery (Situation 3 – Class One)
- Dim LED segment(s) on modules (Situation 4 – Class Two)
The FDA designated three of these software failures as class one recalls and one as a class two.
- Auto ID Module Model 8600
- EtCO2 Module Model 8300
- PC Unit Model 8000
- PC Unit Model 8015
- PCA Module Model 8120
- Pump Module 8100
- SpO2 Module Model 8210 and Model 8220
- Syringe Module 8110
BD Alaris PC Unit Model 8015, PC Unit Front Case with Keypad Replacement Kits
On Aug. 4, 2020, BD recalled 305,526 BD Alaris PC Unit 8015 models and keypad replacement kits manufactured from April 7, 2017 to June 15, 2020.
The company recalled the devices because one or more keys on the keypad could become stuck or unresponsive. This could prevent clinicians from changing medication or fluid infusions and infusion delay.
At the time of the announcement, BD was aware of 1,186 complaints and one reported injury. At the time, there were no reported deaths.
Syringe Module and PCA Module, Syringe/PCA Sizer Sensor Replacement Kit
On Aug. 4, 2020, BD issued a recall for 141,889 of its syringe modules and size sensor kits because PCU units may display the wrong syringe type or size. This could lead to over or under infusion.
The FDA classified this as a class one recall as well.
- PCA Module Model 8120
- Syringe Module Model 8110
- Syringe/PCA Sizer Sensor Replacement Kit P/N 122786
Please seek the advice of a medical professional before making health care decisions.