BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET

    MDR report key: 24681436 · Received March 24, 2026

    Report

    Report Number
    3013876692-2026-00047
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    January 11, 2026
    Report Date
    May 27, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    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. 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. 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. THE HLS SET WAS REPLACED ON (B)(6) 2026. THERE WAS NO LEAKAGE DURING PRIMING PROCEDURE. THE PATIENT REQUIRED A BLOOD TRANSFUSION DUE TO THE LEAKAGE. THE FOLLOWING PATIENT INFORMATION WAS SHARED: MALE, 51 YEARS OLD WITH 90KGS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN POLAND DURING PATIENT TREATMENT. IT WAS REPORTED THAT THE HLS SET HAD A LEAKAGE. THE LEAKAGE WAS LOCATED AT THE GAS OUTLET. THE AFFECTED HLS SET WAS REPLACED TO CONTINUE THE PATIENT'S TREATMENT. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150631 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 3000502782 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1