FDA Class I Recall: BodyGuard Infusion Pump System by CME America

April 1, 2020

CME America is recalling the BodyGuard Infusion Pump Systems because the pumps may have a slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion). The reason for the infusion errors is not known.

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 environments.

Recalled Product -BodyGuard Infusion Pump Systems, all serial numbers of affected model numbers. Model Numbers including refurbished versions are: BG 323 Pump, BodyGuard 121 Twins Pump, BodyGuard 545 ColorVision Pump, BodyGuard 575 Pump, and CMExpress Pumps.

The use of the affected infusion pumps may cause serious adverse health consequences including death. There have been 158 complaints regarding this device issue. There have been no injuries or deaths.

On January 7, 2020 CME America, a subsidiary of Becton Dickinson sent a letter to distributers and customers informing them of the issue and provided the following instructions: 

·       Assess the fluid container for volumes infused, volumes remaining in the container at the end of the infusion, and ensure the total volume of medicine is delivered.

·        Determine if the devices have been calibrated within the last 12 months.

·        If calibration has not occurred within that time frame, customers should contact their Authorized Service Provider to schedule a calibration.

The FDA recommends healthcare professionals take the following actions:

·        Do not use the pump to administer critical medications (e.g., vasopressors) or medications such as insulin where infusion accuracy is important. Testing indicates that pumps may have a delivery inaccuracy of up to ±13%.

·        Depending on your therapy needs, if higher accuracy is required, consider an alternate infusion device.

·        When clinically appropriate, perform periodic pump and patient monitoring to ensure that the infusion is proceeding as intended.

·        If this pump is used in a home care setting, the prescribing clinician, patient and home healthcare provider should determine the appropriateness of the pump for use, and pump / patient monitoring strategies.

Notify CME America if your pump is malfunctioning.

FDA has the announcement.