FDA Adverse Event Malfunction Summary report: N

HEART LUNG MACHINE

MDR report key: 24710806 · Received March 30, 2026

Report

Report Number: 8010762-2026-0000150
Event Type: Malfunction
Date Received: March 30, 2026
Date of Event: March 17, 2026
Report Date: April 27, 2026
Manufacturer: MAQUET CARDIOPULMONARY GMBH
Product Code: KFM
UDI-DI: 04037691718910
PMA / PMN Number: K991864
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW CONSOLE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR ROTAFLOW CONSOLE WITH CATALOG NUMBER 701046405.

Description of Event or Problem · 0

THE EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE ERROR MESSAGE ¿ERROR -12V TEST¿ OCCURRED ON THE ROTAFLOW CONSOLE UPON STARTUP. THE DEVICE WAS REPLACED WITH ANOTHER MACHINE. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE REPORTED FAILURE ¿ERROR -12 V TEST¿ COULD LEAD TO THE PUMP STOP THEREFORE, REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
771225	HEART LUNG MACHINE	PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE	KFM	MAQUET CARDIOPULMONARY GMBH	MCP00706291#ROTAFLOW PUMP MODULE		04037691718910

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown