FDA Issues Oxygenator Device Warning Over Patient Infection Risks

Recalled oxygenator and blood filtration devices may increase infection risks in heart patients, including children, the federal health officials warn.

Healthcare providers are being warned not to use recalled Getinge/Maquet manufactured oxygenator devices and cardiotomy reservoirs, due to packaging problems, which may place patients at risk of developing dangerous infections.

The U.S. Food and Drug Administration (FDA) released a letter to healthcare providers on June 9, urging them to immediately discontinue use of all Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs, since microscopic holes in the packaging may have compromised the sterility.

Quadrox oxygenators are blood/gas exchangers used to remove carbon dioxide from blood and adjust blood temperature for up to six hours during surgical heart procedures. Venous Hardshell cardiotomy reservoirs are used to collect, store, and filter blood for up to six hours in pediatric heart patients undergoing heart surgery.

Getinge/Maquet first announced the problems on May 18, in a voluntary manufacturer recall for all Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs. According to the recall notice, the affected products may have been improperly placed during packaging, potentially causing microscopic holes, creases, or tears compromising device sterility, increasing risk of potentially fatal patient infections.

FDA officials issued the letter to healthcare providers to help ensure that health providers and facilities know of the manufacturer’s recall and have details about alternative devices.

The packaging issue affect all Quadrox Oxygenators, including the following models:

• Quadrox i Adult
• Quadrox i Small Adult
• Quadrox i Pediatric
• Quadrox i Neonatal
• Quadrox iD Adult
• Quadrox iD Pediatric
• Quadrox iR

Specific model numbers are available through the manufacturer’s voluntary recall notice, or through the FDA’s Unique Device Identification System (UDI).

The packaging issue also affects certain Venous Hardshell Cardiotomy Reservoirs. Those affected model numbers are available through the manufacturer’s voluntary recall notice, or through the FDA’s Unique Device Identification System (UDI).

The recalled devices were distributed between April 6, 2020 and December 12, 2022.

FDA Oxygenator Recommendations to Healthcare Providers

The FDA warning specifically recommends that healthcare providers and facilities who use Getinge/Maquet Quadrox Oxygenators and Venous Hardshell Cardiotomy Reservoirs review the manufacturer’s recall notice, check their inventory for affected devices, and stop using affected devices unless they are currently in use.

If recalled devices are currently in use, providers should monitor patients for signs and symptoms of infection, including inflammation, sepsis, and ischemia, the FDA warning indicates. The FDA warning letter also provides a list of several agency approved oxygenators to use in place of the recalled devices.

Getinge/Maquet’s Urgent Medical Device Recall notice provides users with a list of actions to prevent malfunction if they must use the device. The company indicates it is urgently working on a packaging redesign to correct the problem and anticipates a solution by the end of 2023.

In the meantime, customers can contact Getinge/Maquet customer support with questions, including how to return recalled products, at 1-888-943-8872.

Side effects or adverse events should also be reported to the FDA’s MedWatch Adverse Event Reporting Program.