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Infusion Pumps Face Class 1 Recall after 55 Injuries, 1 Death

Alaris System Pumps recalled due to serious errors.

Monday, March 9, 2020 - COVID social distancing rules Becton Dickinson CareFusion 303 is recalling 774,000 Alaris Infusion Pump Systems and its modules due to several problems that can potentially cause death in patients. The FDA has identified this as a Class I recall, the most serious type of recall.

The recalled pumps, used in hospitals and other adult, pediatric, and neonatal care settings to infuse medications and monitor vital signs, have experienced programming delays, battery alarm failures, programming failures, and other problems that can be dangerous to patients.

To-date, 55 injuries and one death have been reported due to under-infusion, over-infusion, delay of infusion, or interruption of infusion of medications.

According to the FDA recall notification the following errors have occurred:

Users utilizing modules with software version 9.33 or earlier have experienced:

Delay options programming

Keep vein open (KVO) / "End of Infusion" alarm priority

Software/System errors (System Error 255-xx-xxx)

Low battery alarm failures

Use-related errors related to custom concentration programming

Users utilizing modules with software version 12.1.0 have experienced:

Low battery alarm failures

Use errors related to custom concentration programming

Keep vein open (KVO)/ "End of Infusion" alarm priority

KVO Rate Not Available When Using Delay Options programming

All lots of the affected models of Alaris System Pumps and modules have been recalled. The following model numbers and units are included in the recall:

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� Pump Module Model 8100, software versions 9.33 and prior, and software version 12.1.0.

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

Alaris PC units with software version 9.33 and older were distributed from July 2004 until October 31, 2019. Alaris PC units with software version 12.1.0 were distributed from December 18, 2019 until January 23, 2020.

Letters were sent to warn hospitals, providers, and consumers of problems with the pumps February 4, 2020. In the letters, Becton Dickinson told customers that the systems may be "vulnerable to the potential risk of multiple system and software errors." Consumers were directed to a pdf list of ways to mitigate some of the risks, and were told they would be notified of a software update when it becomes available.

Health care professionals, patients, or caregivers are asked to report adverse reactions or quality problems to MedWatch online voluntary reporting center.

If you or a loved one has experienced a serious adverse effect due to a faulty medical monitoring device, contact 1-800-RxWatch for a free, no-obligation consultation.

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