On August 4, 2020, BD (Becton, Dickinson and Company), a leading global medical technology company, announced four voluntary recalls affecting the company’s infusion pumps. These are large volume infusion pumps that deliver controlled amounts of medications, fluids, blood products, and blood to patients as needed. Healthcare facilities and hospitals use the devices during a variety of procedures, including those addressing cancer, pain management, critical care, and surgery.
On September 21, 2020, the FDA categorized three of these recalls as Class 1 recalls, which means there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. The last was categorized as a Class II recall, which means the device may cause temporary or medically reversible adverse health consequences.
BD Recalls Four Devices Related to Infusion Pumps
The four BD recalls include:
- Alaris PC Unit Model 8015 Front Case with Keypad Replacement Kits: The keys on the keypad may be unresponsive or stuck, due to fluid ingress, potentially resulting in a delay to the start of infusion or interruption of infusion. The affected units were manufactured from April 7, 2017, to the present.
- Alaris Pump Module Model 8100 Front Case with Keypad Replacement Kits: The same problem—the keys may be unresponsive or stuck. The affected units were manufactured from December 1, 2016 to January 23, 2019.
- BD Alaris Syringe Module Model 8110 and PCA Module Model 8120: The PC unit may display the incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or over-infusion. The affected products were manufactured from March 1, 2010, to the present.
- BD Alaris EtCO2 Module Model 8300 Channel Error: There’s an issue with a component within the device that may result in a channel error. This could result in a delay to the start or interruption of patient monitoring. The affected products were manufactured from January 5, 2018, to January 4, 2019.
The FDA announced on September 21, 2020, that the first three of the recalls had been designated as Class I recalls, while the last was designated as Class II. The classification doesn’t change the guidance provided by BD as to how healthcare providers should proceed
Healthcare facilities that have these devices are advised to call BD’s recall support center at 888-562-6018 or to email the company at SupportCenter@bd.com.
Previous BD Infusion Pump Recall Associated with 55 Injuries
A previous BD recall, implemented February 4, 2020, affected nearly 775,000 BD Alaris infusion pumps. The products had multiple system errors, software errors, and user-related errors. For modules with software version 9.33 or earlier, there were delay options for programming, low battery alarm failures, user-related errors related to custom concentration programming, and more.
For modules with software version 12.1.0, there were also issues with low battery alarm failures and user errors, as well as other errors that could result in a delay of infusion, interruption of infusion, or slower than expected delivery of medication (under-infusion) or faster than expected delivery (over-infusion).
At the time of the recall, the company was aware of 55 reported injuries related to the products, and one death.
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