FDA Adverse Event Malfunction Summary report: N

HEART LUNG MACHINE

MDR report key: 24906733 · Received April 17, 2026

Report

Report Number: 8010762-2026-0000182
Event Type: Malfunction
Date Received: April 17, 2026
Date of Event: April 1, 2026
Report Date: April 16, 2026
Manufacturer: MAQUET CARDIOPULMONARY GMBH
Product Code: DTQ
PMA / PMN Number: K943803
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS ONSITE FOR FURTHER INVESTIGATION OF THE DEVICE. THE FST SUSPECTED THE PUMP CONTROL BOARD TO BE DEFECTIVE. FURTHER INVESTIGATION IS ONGOING. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. NOTE: THIS EVENT OCCURRED ON THE CHINESE MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT HL 20¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K943803. 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 HL 20 WITH CATALOG NUMBER 701043262.

Description of Event or Problem · 0

THE EVENT OCCURRED IN CHINA DURING STARTUP OF THE DEVICE. IT WAS REPORTED THAT THERE WAS AN ERROR ¿ER09¿ DISPLAYED ON THE HL20 PUMP. NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL 20 SERVICE MANUAL THE ERROR MESSAGE ¿ER09¿ INDICATES THAT +12V-SUPPLY VOLTAGE WAS OUT OF TOLERANCE DURING THE SELF-TEST FAILED. SINCE THE ERROR "ER09" COULD LEAD TO AN UNINTENTIONAL PUMP STOP A REPORT IS REQUIRED IN US. COMPLAINT ID: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
971021	HEART LUNG MACHINE	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS	DTQ	MAQUET CARDIOPULMONARY GMBH	HL 20

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown