FDA WedWatch – Bio-Console 560 Extracorporeal Blood Pumping Console by Medtronic Perfusion Systems:

TOPIC: Bio-Console 560 Extracorporeal Blood Pumping Console by Medtronic Perfusion Systems: Class I Recall – Due to Possible Electrical Failure Causing the Pump to Stop

AUDIENCE: Patient, Health Professional, Risk Manager

ISSUE: Medtronic is recalling the Bio-Console 560 Extracorporeal Blood Pumping Console due to reports of electrical failure causing the device to stop. Other issues observed by users include the interface going blank, smoke coming from the device and a burning odor during use.

In cases where the pump stopped or the interface went blank, users had to operate the pump using a hand crank until the device restarted or could be replaced by a backup unit.

If the pump stops, patients could experience:

• Insufficient blood flow potentially leading to organ dysfunction
• Blood clots potentially leading to low blood pressure
• Reversible or irreversible neurological dysfunction
• Death

There have been nine complaints reported about this device issue, including three injuries. No deaths have been reported.

For more information about this recall, click on the red button “Read Recall” below.

BACKGROUND: The Bio-Console 560 Extracorporeal Blood Pumping Console is used to pump and return blood to a person during cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery. The cardiopulmonary bypass procedure provides both circulatory and breathing support to a person whose heart and lungs are too weak to pump enough blood to the rest of the body.

The Bio-Console 560 can pump blood for up to six hours each time used.

RECOMMENDATION: On March 3, 2021, Medtronic sent an Urgent Medical Device Correction letter to all affected distributors and customers. The letter requested that customers take the following actions:

• Review the Customer Notification Detail Report sent with the letter to identify potentially affected devices.
• Use unaffected Bio-Console 560 devices, if available, until correction has been completed for affected Bio-Console 560 devices.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.