Alaris Infusion Pump Recalled Due to Unresponsive or Stuck Keys

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The Alaris Infusion Pump (Model 8100) is used to deliver fluids into a person’s body in controlled amounts such as nutrients, medications, blood, and other therapies. Continue reading to learn the latest class I recalls by the FDA regarding Alaris Infusion Pumps.

Alaris Infusion Pump Recalled Due to Unresponsive or Stuck Keys

The FDA reported the recall of Care Fusion 303’s BD Alaris Pump Module 8100 due to unresponsive or stuck keys during operation on April 16th, 2021. This is a class I recall where the devices may cause serious injuries or death. This recall specifically affects model 8100 with part numbers 49000239, 49000346, 49000438, and 49000439 manufactured between January 15–December 5, 2019 and distributed from January 23–December 5, 2019, affecting 145,492 devices. The recall is separate from the BD Alaris Pump Module 8100 keypad recall dated August 4, 2020.

BD said that when there is a fault with the keypad, the device continues to infuse a drug or other substance as programmed, though users may be unable to make programming changes. A fault with the keypad could delay the start of an infusion. If the settings need changing mid-infusion, the user may need to stop the process and restart using a different device. Such delays could have severe consequences in patients receiving infusions that are critical to their survival. As of the end of July, BD has received one report of a serious injury. They reported that the fault could theoretically lead to deaths.

Alaris PC Unit Model 8015 has also been recalled by the FDA and a handful of different keypad replacement kits due to being prone to having unresponsive or stuck keys. Stuck keys are effectively constantly pressed. This recall affects more than 300,000 devices.

Alaris Infusion Pump Recalled Due to Possible Cracked or Separated Bezel Repair Posts

Due to two reports of cracks and separations in the bezel repair posts, on April 19th, 2021, the FDA reported Tenacore’s February 25, 2021, recall of 474 BD Alaris System model 8100 devices which recalled  2,001 devices. These reports caused the following: Free flow of fluids, over-delivery or under-delivery of fluids, interruption of fluids delivered, device leaking, device component burning or smoking, and power supply failure or malfunction. FDA considers this Tenacore recall class I.
On April 30, 2021, FDA reported Pacific Medical Group’s recall of 2,452 devices on March 24, 2021 regarding 62 reports and one death involving the cracked bezel problems. This is considered a class I recall.

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