News & Press: Patient Safety

CME America Expands Recall of BodyGuard Infusion Administration Sets

Thursday, August 6, 2020  
SIS Patient Safety Alert 08/06/2020: CME America Expands Class I Recall of BodyGuard Infusion Administration Sets Due to Risk of Over-, and Under-infusion

This is an important alert from the Spine Intervention Society. SIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither SIS nor the FDA endorse either the product or the company.

ISSUE: CME America is updating their previously announced recall from April 27th because the BodyGuard Infusion System Administration Sets may have a slower than expected delivery of medication (under-infusion), faster than expected delivery of medication (over-infusion) or a delay in therapy. The reason for the infusion errors is not known.

Depending on the medication used in the affected infusion pump it may cause serious adverse health consequences including death. There have been 165 complaints regarding this device issue but no injuries or deaths.

For a complete list of affected products please read the entire recall announcement.

BACKGROUND: The BodyGuard Infusion Pump System delivers fluids and medications into a patient's body in controlled amounts. The pump provides fluids through an infusion tubing set into a patient's vein or through other cleared routes of administration. The system can be used in hospitals and home care settings.

On April 27th, 2020 CME sent a letter to customers telling them that the company is removing the BodyGuard Infusion Pumps, accessories, and infusion sets from the market. The letter asked customers to:

  • Share this notice with appropriate personnel
  • Identify and remove any remaining inventory of infusion sets, and discard.
  • Complete the Customer Response Form, even if there are no affected products in inventory.

On June 16th, 2020, CME sent an updated letter to customers notifying them of additional testing that was performed on the infusion sets used with their BodyGuard Infusion Pump System. The additional testing noted some sets do not meet the ±5% delivery accuracy level of the system or the ±13% accuracy level identified in the earlier recall notification; therefore, the use of the pump system could cause over-infusion or under-infusion of therapy and patient harm.

The letter to customers includes tables clarifying which infusion sets are still able to be used, some of which have a new maximum flow rate, and which infusions sets cannot be used.

RECOMMENDATION: Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source: Food and Drug Administration - Accessed 08/06/2020

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