In March, the FDA designated the CME America BodyGuard microset infusion sets recall as Class I — its most serious level — after complaints of under-infusion related to the sets.
CME America initiated the U.S. recall of the sets (catalog number A120-003XYVA) on Sept. 6, 2019, recalling 91,500 devices that had been distributed between Oct. 6, 2017, and July 15, 2019. All lots of the affected catalog number were recalled after the company found that the specific infusion sets that have an extended section of tubing that runs longer than standard lengths prohibitively restrict medication flow to the pumping chamber of the infusion pump.
If this happens, it could result in under-infusion, the patient may not receive the appropriate treatment and there could be serious adverse health consequences, including death. In September, the company told customers to discard all affected infusion sets, ensure that all users are aware of the recall and report adverse events to the FDA’s MedWatch adverse event reporting program.
The company then recalled all models of the BodyGuard infusion pumps, totaling 28,400 devices, in January of this year. The company saw an issue where pumps may not deliver fluid at the accuracy specified in the instructions, but, to date, no injuries were reported related to the Class I recall.
CME America supports the use of the affected pumps in accordance with the operator’s manual and additional mitigations, while it will also offer product service and repair activities at its authorized depots. The company plans to implement a phased market removal in order to help limit clinical disruption and allow for patient focus during the COVID-19 pandemic, according to an FDA news release.