BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET

    MDR report key: 21593205 · Received March 13, 2025

    Report

    Report Number
    21593205
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 16, 2025
    Report Date
    February 26, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CVL (CARDIOVASCULAR LAB) STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) TEAM CALLED IN TO HAVE ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) CANNULATION AND INITIATION STARTED ON A CCU (CORONARY CARE UNIT) PT (PATIENT). PT BROUGHT DOWN TO CATH LAB AND ECLS (EXTRACORPOREAL LIFE SUPPORT) TEAM STARTED SETTING UP ECMO DEVICE WHILE THE PROVIDER AND CVL STAFF BEGAN GETTING ACCESSES FOR SHEATH CANNULATION. SHEATH CANNULATION COMPLETED. ECMO DEVICE WAS FILLING AND CIRCULATING FOAM AND UNABLE TO CONNECT TO PT. ECLS TEAM NEEDED TO GO SET UP A NEW KIT AND PUMP UPSTAIRS. PT WAS CONNECTED TO A NEW ECMO SET 1 HOUR AFTER CATH LAB TEAM ACHIEVED CANNULATION OF BILATERAL FEMORAL AND RETROGRADE ACCESS. ADDITIONAL 15 MINUTES FROM THE TIME THE PT WAS CONNECTED TO PUMP TO THE PT RECEIVING OXYGENATED BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804170 HLS SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA 3000395031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown