Warning on Getinge/Maquet Cardiohelp System

An FDA letter to healthcare professionals is warning about potential insufficient packaging sterility with a disposable part of the Getinge/Maquet Cardiohelp system. The blood oxygenation and carbon dioxide removal system is used to pump blood through the extracorporeal bypass circuit for either circulatory support, pulmonary support, or both, for up to six hours.

The disposable part is the HLS Set Advanced that contains the oxygenator, heat exchanger, and integrated centrifugal pump, the agency says. “On 2/13, Getinge/Maquet issued an Urgent Medical Device Correction to inform users about potential problems with packaging sterility for the HLS Set Advanced products,” it says, adding that FDA is not aware of reports of adverse events due to the issue to date.

Additionally, FDA says it is working with Getinge/Maquet to ensure the necessary packaging validation testing for HLS Set Advanced is completed and the issue is resolved.