FDA Adverse Event Malfunction Summary report: N

HEART LUNG MACHINE

MDR report key: 25313154 · Received May 28, 2026

Report

Report Number: 8010762-2026-0000261
Event Type: Malfunction
Date Received: May 28, 2026
Date of Event: May 7, 2026
Report Date: May 28, 2026
Manufacturer: MAQUET CARDIOPULMONARY GMBH
Product Code: DTQ
UDI-DI: 04037691773032
PMA / PMN Number: K943803
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON (B)(6) 2026. THE FAILURE COULD BE REPRODUCED AND THE MCP00151005#CLS 20-535 CAPACITIVE LEVEL (MATERIAL# (B)(4)) NEEDS TO BE REPLACED. 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. THIS EVENT OCCURRED ON THE TURKEY MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO "VARIO TWIN, HL 20 4-PUMPS", WHICH IS SOLD IN THE US UNDER PREMARKET SUBMISSION NUMBER K943803 FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. FOR D4 UNIQUE IDENTIFIER (UDI)#, PRIMARY DI NUMBER HAS BEEN USED FOR VARIO TWIN, HL 20 4-PUMPS WITH CATALOG NUMBER 701043262, WHICH IS SOLD IN THE US. PROVIDED D4 SERIAL NUMBER AND H4 DEVICE MANUFACTURER DATE CORRESPOND TO DEVICE INVOLVED IN THE EVENT, NOT AVAILABLE IN US.

Description of Event or Problem · 0

THE EVENT OCCURRED IN TURKEY DURING A ROUTINE CHECK. IT WAS REPORTED THAT THE ERROR MESSAGE "SENSOR FAULT" WAS DISPLAYED FOR THE LEVEL SENSOR. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
426911	HEART LUNG MACHINE	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS	DTQ	MAQUET CARDIOPULMONARY GMBH	HL 20		04037691773032

Patients

Seq	Age	Sex	Outcome	Treatment
1