BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24342550 · Received February 16, 2026

    Report

    Report Number
    8010762-2026-0000063
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 7, 2026
    Report Date
    April 21, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 GERMAN 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 701069073.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN GERMANY DURING PATIENT TREATMENT, INVOLVING AN HLS SET. IT WAS REPORTED THAT 3-4 HOURS AFTER STARTING THE ECMO PROCEDURE, IT WAS DISCOVERED, THAT THE INVOLVED HYPOTHERMIA DEVICE (DELTASTREAM HC - MANUFACTURED BY XENIOS) WAS NO LONGER FUNCTIONING. THE WATER PUMP WAS NOT WORKING; THERE WAS NO WATER FLOW. SUBSEQUENTLY, IT WAS FOUND THAT BLOOD WAS LEAKING FROM THE WATER CONNECTIONS OF THE HLS SET OXYGENATOR. BLOOD AND BLOOD CLOTS WERE FOUND IN THE TUBING SYSTEM AND IN THE WATER TANK OF THE HYPOTHERMIA DEVICE. AS A RESULT, BOTH THE HLS SET AND THE HYPOTHERMIA DEVICE WERE REPLACED. THE FURTHER TREATMENT OF THE PATIENT PROCEEDED WITHOUT ANY COMPLICATIONS. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS LEAKING AND HAS BEEN REPLACED DURING PATIENT TREATMENT A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560551 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000505729 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female