FDA Designates CME America’s Two Previous Recalls Of Infusion Pumps As Class I

The U.S. Food and Drug Administration (FDA) has now classified the two previously announced recalls for BodyGuard infusion pumps and infusion sets by CME America, a wholly owned subsidiary of medical technology company Becton, Dickinson and Co. or BD, as Class I recalls.

This is classified by the FDA as a Class I recall, which indicates “a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.”

Following FDA’s latest action, the company has decided to suspend distribution of the BodyGuard infusion pump systems and to remove all existing products from the U.S. market.

In early January, the company initiated a recall for the infusion pumps as under certain scenarios the pumps may not deliver fluid at the accuracy specified in the instructions for use that could result in a slower than expected delivery of medication (under-infusion), and/or faster than expected delivery of medication (over-infusion).

The inspection results indicate that pumps may have a delivery inaccuracy of up to about 13 percent. To date, no reports of patient injury has been received related to this recall.

The BodyGuard infusion pump is designed to deliver fluids or medications into a patient’s body in controlled amounts. Typical applications for the pumps include but are not limited to chemotherapy, pain management, TPN, enteral nutrition fluids and antibiotics.

The recall and market removal affects seven models of the BodyGuard infusion pumps and approximately 28,400 devices.

Earlier in September 2019, the company recalled certain lots of BodyGuard Microset infusion sets, when used with the BodyGuard infusion pump, may under-deliver fluids up to 50% at the highest flow rates.

At the time of the recall, CME America informed customers to discard all remaining inventory of the infusion sets and committed to reimbursing impacted customers. To date, no reports of patient injury has been received related to these infusion sets, but CME America immediately stopped shipments of the affected infusion sets.

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