Drug Safety Alerts

Body Guard Infusion Pump System Class I Recall

3/30/2020

On March 30, 2020, the United States Food and Drug Administration (FDA) issued communication regarding a Class I recall of BodyGuard Infusion Pump System manufactured by CME America. This recall was issued because the pumps may have a slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion). Either of these potential issues with infusion rate may represent a potential health hazard or safety risk to patients who may be using product affected by this recall. The reason for the infusion errors is not known.

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.

A list of the affected products is provided here:

Previously 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.

• Complete the Customer Response Form attached to the letter and return it to the CME America, whether the product was in inventory or not.

• Report any adverse events to the FDA’s MedWatch Adverse Event Reporting program.

The FDA recommends health care 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.

CVS Caremark Response: These products are not carried by CVS Caremark Mail Service Pharmacies.

For more information, please call CME America Customer/Technical Support toll-free at 1-877- 263-0111, Monday through Friday, 9:00 am through 5:00 pm (MT). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit https://www.fda.gov.