BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24112868 · Received January 20, 2026

    Report

    Report Number
    8010762-2026-0000018
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 5, 2026
    Report Date
    May 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION WAS RECEIVED ON 2026-03-20 THAT THE HLS SET WAS PRIMED ACCORDING TO STANDARD PROCEDURE PRIOR TO CONNECTION ON 2025-12-19. THERE WERE NO ISSUES OBSERVED DURING PRIMING PROCEDURE. AS ANTICOAGULATION HEPARIN AND ANTITHROMBIN (WITH SUPPLEMENTATION DUE TO LOW LEVELS) WERE USED. ANTICOAGULATION WAS USED ON THE PATIENT DURING THE ENTIRE EXTRACORPOREAL SUPPORT (ECMO). THE REPORTED CLOTS WERE LOCATED ON THE OXYGENATOR INLET AND OUTLET SIDE. THE FOLLOWING PATIENT INFORMATION WAS SHARED: MALE, 31 YEARS OLD WITH 90 KGS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE POLISH 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. NO UDI INFORMATION (PRIMARY DI NUMBER) HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE POLISH 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. NO UDI INFORMATION (PRIMARY DI NUMBER) HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED.

    Description of Event or Problem · 0

    COMPLAINT ID# (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN POLAND. IT WAS REPORTED THAT DURING PATIENT TREATMENT FOR A HEART TRANSPLANTATION (HTX), SUPPORTED WITH ECMO, CLOT FORMATION WITHIN THE ECMO CIRCUIT OCCURRED. THE PATIENT WAS ON A CONTINUOUS HEPARIN INFUSION AND RECEIVED SUPPLEMENTATION WITH FIBRINOGEN AND ANTITHROMBIN. DURING ECMO THERAPY, A DROP IN FIBRINOGEN LEVEL BELOW 1 G/L WAS OBSERVED. AS CLOTTING WAS OBSERVED, THE AFFECTED HLS SET WAS REPLACED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS REPLACED DURING THE PATIENTS TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552211 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000502781 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male