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Update on CME America BodyGuard Infusion Pumps and Sets Class I Recall


May 11, 2020

WASHINGTON, D.C. — CME America announced an update concerning its voluntary recall of two infusion pumps. The recalls for both CME America BodyGuard Infusion pumps and infusion sets are designated Class I by the U.S. Food and Drug Administration (FDA). The Class I designation assigned to the recall by the FDA indicates that health authorities believe that continued use of the recalled devices poses an elevated threat to cause the patient severe adverse health consequences or prove to be fatal. CME America said that the recall program for its pumps and infusion were both voluntary.  Notwithstanding, CME America notified its customers that it would stop distributing its BodyGuard Infusion pump system and pull all existing products from the market in the United States. *

CME America recalled the BodyGuard pumps and infusion sets because the pumps failed to deliver the correct doses. CME America determined that their pumps would deliver an insufficient dose of fluids or medication when the medical device failed. The company further describes the malfunction as over-infusion or under-infusion. The inaccuracy of the device was astounding. Tests showed that the faulty medical devices delivered fluids and medication with as much as a thirteen percent inaccuracy level.

CME America acknowledged the inherent risks involved with continued utilization of a pump and infusion set that administers incorrect doses of medication. CME America initially told customers that they could continue using the devices provided that the user took extra precautions to avoid over-infusion or under-infusion until the devices were removed from circulation. CME America said that it is taking extra steps to mitigate problems associated with the COVID-19 pandemic. 

CME America designed the BodyGuard to administer medication or fluid to patients in a controlled manner. The company's recall initiative will removal 28,400 medical devices from the market. The recalled devices are used in outpatient settings most commonly.  CME America said that there had been no adverse events reported.

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Source:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cme-america-provides-update-two-previously-announced-voluntary-recalls-related-ambulatory-infusion

Category: Product Liability

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