Following reports of problems with BodyGuard Infusion systems, which may deliver incorrect doses of fluid and medications, nearly 5 million infusion systems used with the delivery systems are being recalled nationwide.
The BodyGuard Infusion Pump System recall was announced by the FDA on August 5, indicating that it is a Class I medical device recall, suggesting that continued use of the product may pose a risk of serious injury or death.
The action was taken after the manufacturer received at least 165 complaints of the pumps under or over delivering fluid or medications to patients, as well as failing to operate in a timely manner, which may result in a critical delay in treatment.
The recalled infusion pumps and sets involves several types of BodyGuard Infusion Pump Systems, which are designed to deliver medication through an infusion tubing placed into a patient’s vein or through other avenues of administration. The impacted infusion pump systems are designed for use in adult, pediatric and neonatal care patients in hospitals and home care settings.
Roughly 30,000 BodyGuard Infusion Pump Systems were recalled in March by manufacturing company Caesarea Medical Electronics Ltd (CME). However, since the initial announcement, that number has been increased to just under five million units, after a total of 165 customer complaints were received, indicating additional models of the BodyGuard Pump systems also over or under delivered fluids, as well as causing delays in patients treatment.
On June 16, CME sent a letter updating their customers that additional testing had been performed on infusion sets used with the BodyGuard Infusion Pump System and identified some sets do not meet the ±5% delivery accuracy level of the system or the ±13% accuracy level identified in the earlier recall notification.
As a result of the test reports, CME has identified an additional 4,877,792 BodyGuard Infusion Pump Systems that may cause over or under infusion of therapy to patients, resulting in an expansion of initial March 2020 recall.
The recall involves BodyGuard BodySet, BodyGuard Microsets, BodyGuard set with Female Luer, BodyGuard Microsets with Filter, BodyGuard Microset with Filter and Manual Priming Valve, and BodyGuard Microset with Male Luer Connectors.
The products were manufactured by CME from March 06, 2009 to November 26, 2019 and were distributed throughout the United States to hospital and healthcare centers from May 6, 2016 through May 11, 2020.
The FDA has given the recall a Class I designation, meaning the agency believes the problems with the medical device could cause serious injuries or death. Officials announced they are continuing to monitor adverse events reports on the BodyGuard infusion systems and that no deaths have been reported in relation to the recall.
The manufacturer and FDA instruct customers to identify and remove any remaining inventory of impacted infusion sets and discard them. For additional questions or concerns regarding the recall customers may contact CME America’s Technical Support by phone at (877) 263-0111.