BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24951636 · Received April 22, 2026

    Report

    Report Number
    8010762-2026-0000186
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 8, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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 (B)(6) 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 SLOVAKIA. IT WAS REPORTED THAT BROKEN TUBE CONNECTED TO A THREE-WAY TAP FOR SAMPLING. NO ADDITIONAL INFORMATION WAS RECEIVED. NEW INFORMATION RECEIVED ON 2026-04-08 THAT THE FAULT WAS RECOGNIZED DURING ECMO STARTUP. THE HLS SET WAS NOT REPLACED, BUT THE DAMAGED TUBE WAS REPLACED. FOLLOWING PATIENT INFORMATION WAS SHARED: 31-YEAR-OLD FEMALE WITH 50KG. DUE TO THE BROKEN TUBE, THERE WAS A LEAKAGE. THE PROVIDED VIDEO EVIDENCE SHOWS A LEAKAGE ON THE VENOUS SAMPLING LUER LOCK CONNECTOR. AS A LEAKAGE DURING TREATMENT CAN CAUSE HIGH BLOOD LOSS AND REPRESENTS A RISK FOR THE PATIENT, A REPORT IS REQUIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512060 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1