BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART LUNG MACHINE

    MDR report key: 24053485 · Received January 13, 2026

    Report

    Report Number
    3013876692-2026-00002
    Event Type
    Death
    Date Received
    January 13, 2026
    Date of Event
    December 16, 2025
    Report Date
    April 2, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    UDI-DI
    04037691258997
    PMA / PMN Number
    K991864
    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

    ON 2026-04-01 THE SSU (SALES AND SERVICE UNIT) PROVIDED THE CORRECT SERIAL NUMBER OF THE INVOLVED ROTAFLOW DRIVE (RFD). THE SERIAL NUMBER OF THE RFD IS (B)(6). THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (ROTAFLOW) HAS BEEN MANUFACTURED ON 2012. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE EGYPT MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "BASE UNIT, ROTAFLOW DRIVE¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K991864. 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 ROTAFLOW DRIVE WITH CATALOG NUMBER 701022161.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN EGYPT DURING TREATMENT. IT WAS REPORTED THAT THE PLS DRIVE FAILED AND THE PUMP STOPPED. THEREFORE, THE PLS SET AND HARDWARE WERE REPLACED TO A HLS SET AND CARDIOHELP DEVICE. FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT WAS CONNECTED TO V-A ECMO DUE TO A CARDIOGENIC SHOCK AND ARRESTED AFTER CANNULATION AND THEN HAD A RETURN OF SPONTANEOUS CIRCULATION (ROSC). LATER THE PATIENT ARRESTED A SECOND TIME WITH NO ROSC AFTER 36 HOURS. FOLLOWING PATIENT INFORMATION WAS SHARED: 16 YEARS OLD MALE WITH 70KG AND 170CM. NEW INFORMATION WAS RECEIVED ON 2026-01-07 THAT THE FAILURE WAS THAT THE CUSTOMER WAS NOT ABLE TO RAISE THE FLOW. THEREFORE, THE PLS SET AND ROTAFLOW WERE IMMEDIATELY REPLACED TO AN HLS CIRCUIT WITH CARDIOHELP DEVICE. NO ALARM MESSAGE WAS DISPLAYED ON THE ROTAFLOW DEVICE. THE PATIENT ARRESTED IMMEDIATELY AFTER CONNECTION TO THE VA ECMO. THE FIRST CARDIAC ARREST WAS ON (B)(6) 2025 ON THE PLS SET/ROTAFLOW. THE SECOND CARDIAC ARREST WAS ON (B)(6) 2025 ON THE HLS SET/CARDIOHELP. THE CUSTOMER PERFORMED ADVANCED CPR, BUT THE PATIENT PASSED AWAY. THE PATIENT WAS CONNECTED TO THE ECMO DEVICE DUE TO SEVER CARDIOGENIC SHOCK. THE PATIENT HAD NO PRE MEDICAL HISTORY; HE WAS PRESENTED DUE TO A POST ALUMINIUM PHOSPHIDE POISONING. THE CONFIRMATION WAS RECEIVED BY THE CUSTOMER THAT THE HLS SET/CARDIOHELP HAD NO FAULTS. THE AFFECTED PLS SET IS NOT AVAILABLE FOR TECHNICAL INVESTIGATION. FURTHER THE PLS SET WAS PRIMED ON THE SAME DATE WHEN ECMO STARTED ((B)(6) 2025). THIS COMPLAINT IS RELATED WITH THE PLS SET OT (B)(6). AS THE PATIENT ARRESTED DURING TREATMENT AND THE ROTAFLOW DEVICE WAS REPLACED, A REPORT IS REQUIRED. THE PATIENT PASSED AWAY. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111931 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW DRIVE UNIT, BLUE 04037691258997

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Death