BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 24112870 · Received January 20, 2026

    Report

    Report Number
    8010762-2026-0000019
    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

    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. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER 701069073.

    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 (B)(6) 2025. THERE WERE NO ISSUES OBSERVED DURING PRIMING PROCEDURE. AS ANTICOAGULATION HEPARIN AND ANTITHROMBIN (WITH SUPPLEMENTATION DUE TO LOW LEVELS) WERE USED DURING THE ENTIRE EXTRACORPOREAL SUPPORT (ECMO). THE REPORTED CLOTS WERE LOCATED ON THE OUTLET AND INLET SIDE OF THE OXYGENATOR. THE AFFECTED HLS SET WAS REPLACED ON (B)(6) 2026. THE FOLLOWING PATIENT INFORMATION WAS SHARED: MALE, 51 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. 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 POLAND. IT WAS REPORTED THAT DURING PATIENT TREATMENT FOR A HEART TRANSPLANTATION (HTX), SUPPORTED WITH ECMO, CLOT FORMATION WITHIN THE ECMO CIRCUIT OCCURRED. A FIBRINOGEN LEVEL BELOW 1 G/L WAS OBSERVED. THE BLOOD GAS ANALYSIS INDICATED A NEED FOR FIO2 100% AND FLOW OF APPROXIMATELY 200. AS CLOTTING WAS OBSERVED, THE AFFECTED HLS SET WAS REPLACED. A SUBSEQUENT EXCHANGE IS CURRENTLY PLANNED AFTER APPROXIMATELY ONE WEEK OF THERAPY. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS THE HLS SET WAS REPLACED DURING THE PATIENT'S TREATMENT, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532328 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000506418 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male