FDA Adverse Event Malfunction Summary report: N

TUBING SET

MDR report key: 25253186 · Received May 22, 2026

Report

Report Number: 8010762-2026-0000253
Event Type: Malfunction
Date Received: May 22, 2026
Date of Event: February 23, 2026
Report Date: May 22, 2026
Manufacturer: MAQUET CARDIOPULMONARY GMBH
Product Code: DTZ
UDI-DI: 04058863078298
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HU
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE HUNGARY MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. 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 HLS SET WITH CATALOG NUMBER 701069076.

Description of Event or Problem · 0

THE EVENT OCCURRED IN HUNGARY. IT WAS REPORTED, THAT DURING ECMO TREATMENT AN HLS SET WAS INSTALLED ON A CARDIOHELP SYSTEM. AFTER INSTALLATION THE SYSTEM DISPLAYED THE ERROR MESSAGE: ¿PUMP ERROR SINGLE USE PRODUCT ¿ STOP.¿ THE AFFECTED CARDIOHELP DEVICE WAS REPLACED TO EXCLUDE A MALFUNCTION, HOWEVER THE SAME ISSUE REMAINED. A NEW HLS SET WAS OPENED AND INSTALLED. AFTER THIS REPLACEMENT THE ECMO TREATMENT COULD BE CONTINUED SUCCESSFULLY WITHOUT FURTHER ISSUES. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS DEVICE REPLACEMENTS TOOK PLACE DURING THE PATIENTS TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
263417	TUBING SET	OXYGENATOR, CARDIOPULMONARY BYPASS	DTZ	MAQUET CARDIOPULMONARY GMBH	HLS SET	3000464735	04058863078298

Patients

Seq	Age	Sex	Outcome	Treatment
1