The US Food and Drug Administration (FDA) is providing information to health care providers and facilities on oxygenator devices used in extracorporeal circulation following a recall notice by Getinge/Maquet.
On May 18, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users not to use all Quadrox Oxygenators and certain Getinge/Maquet Venous Hardshell Cardiotomy Reservoirs due to potentially compromised packaging sterility that may result in the risk of infection/harm to the patient.
The FDA issued a letter to help ensure that health care providers and facilities are aware of the manufacturer’s recall notice and have information about alternative devices.
The FDA recommends health care providers and facilities that use Getinge/Maquet Quadrox Oxygenators and Venous Hardshell Cardiotomy Reservoirs:
- Review the recall notice from Getinge/Maquet for all Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs.
- Check your inventory to determine if you have any Quadrox Oxygenators or certain Venous Hardshell Cardiotomy Reservoirs.
- Do not use these devices unless they are already in use.
- If a Quadrox Oxygenator or specified Venous Hardshell Cardiotomy Reservoir is already in use, these devices may continue to be used. Monitor patients for the following signs and symptoms, and, if detected, treat the patient according to clinical protocols: inflammation, infection, sepsis, and ischemia.
- For new extracorporeal circulation procedures, use alternative device(s) instead of Getinge/Maquet Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs. Look for other manufacturers or suppliers of oxygenators to determine if alternatives are appropriate.
- Report any issues with oxygenators to the FDA.
Oxygenator devices are blood-gas exchangers used to provide physiological gas exchange for up to six hours during cardiopulmonary bypass procedures, or for more than six hours during extracorporeal membrane oxygenation procedures.
The Venous Hardshell Cardiotomy Reservoir is used to collect, store, and filter blood in extracorporeal circulation in cardiopulmonary bypass procedures for up to six hours.
Affected Devices
The following Medical Device Recall Database entries for Getinge/Maquet Quadrox Oxygenators and certain Venous Hardshell Cardiotomy Reservoirs include Unique Device Identifier information provided by the manufacturer. The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use:
- Quadrox i Adult
- Quadrox i Small Adult
- Quadrox i Pediatric
- Quadrox i Neonatal
- Quadrox iD Adult
- Quadrox iD Pediatric
- Quadrox iR
- Venous Hardshell Cardiotomy Reservoir
The FDA states in the notice that it will continue to work with health care providers and facilities to assist with challenges related to available options for oxygenator devices and that it is working with Getinge/Maquet to monitor for any adverse events related to its recall.
The FDA is interested in hearing from health care providers and facilities that have trouble obtaining medical devices, including oxygenators. Email the FDA at [email protected].
