FDA doles out Class I rating to recall of replacement part for BD's Alaris infusion pump

A new group of recalls for a repair piece installed in some of BD’s Alaris infusion pumps joins more than a dozen others on the long list of serious recalls involving the device in the last decade.

The latest round of safety notices were issued not by BD, but by a handful of biomedical equipment repair companies that have serviced or repaired the infusion pumps using new bezel pieces, which make up some crucial pieces of the interior mechanism of the pump.

According to the recalls, these replacement bezel components have been found to be prone to cracking or separating, which can affect the pump’s fluid delivery, potentially resulting in under-delivery, over-delivery or the free flow of fluids to a patient.

So far, since April, six repair service providers have issued recalls: Bio-Medical Equipment Service Co., The Biomed Guys, Infusion Pump Repair, Step-Har Medical, Avante Health Solutions and Tenacore.

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In total, their recalls affect 3,683 of the Alaris infusion pump modules, all of which are model 8100. The bezel components were distributed throughout the U.S. between July 2020 and March of this year, with the bulk of them coming from Kentucky-based Avante Health Solutions.

Each of the recalls has been categorized as Class I by the FDA, indicating the defective bezel assembly’s high risk of causing serious injury or death. To date, across the six companies, 64 complaints have been filed, with no injuries linked to the replacement part and one death possibly related, per Avante’s recall notice.

Healthcare providers with Alaris pumps that were repaired using the affected parts have been asked to immediately quarantine the devices and contact the original repair service provider to schedule installation of a replacement bezel component, which must be completed before the infusion pumps can continue to be used.

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The Alaris pumps are used by hospitals to deliver controlled amounts of medications, nutrients, blood and other fluids into patients' bodies. The large-volume pump is designed to be able to dispense up to four separate infusions at once—from add-on infusion modules like the model 8100—controlled by an LCD screen and keyboard on the main unit.

For much of its lifetime, however, the Alaris line of infusion pumps and add-on components has been plagued by technical issues. According to the FDA’s recall database, the Alaris devices have been the subject of about two dozen Class I recalls since 2006.

Earlier this year, the model 8100 component was recalled by BD after an issue arose in which the module’s keypad could separate from the rest of the device during an infusion if liquid had gotten behind the keypad during cleaning. If the keypad was raised, the keys could stick or become unresponsive, therefore posing a risk of delaying or interrupting infusions.

And, in early 2020, the company issued one of its most wide-ranging Class I recalls of the Alaris pumps to date. Spanning 774,000 Alaris pumps, the recall covered a handful of system, software and use-related errors linked to the embedded software. Those errors could potentially lead to delays and interruptions in infusions, or the under- or over-delivery of fluids.

At the time of the recall, the issues had been linked to at least 55 injuries and one death.