BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM

    MDR report key: 19109994 · Received April 15, 2024

    Report

    Report Number
    3004582654-2024-00022
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 19, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2024-04-22 THE BLOOD PUMP IN QUESTION WAS RETURNED TO BERLIN HEART GMBH FOR INVESTIGATION. DURING VISUAL INSPECTION, NO ABNORMALITES WERE DETECTED. THE BLOOD PUMP WAS CLEANED AND DISINFECTED TO TEST ITS FUNCTIONALITY. THE PUMP PERFORMANCE MET THE SPECIFICATIONS. THE PUMP WAS COMPLETELY FILLING AND EMPTYING, AND THE MEMBRANE MOVEMENT SHOWED NO ABNORMALITIES. THE BLOOD PUMP WAS THEN OPENED, AND THE INDIVIDUAL MEMBRANE LAYERS WERE EXAMINED. ALL THREE LAYERS WERE INTACT AND THE GRAPHITE DISTRIBUTION WAS UNIFORM WITHOUT ANY GAPS. THE STABILIZATION RING WAS WITHOUT ANY DEFECTS. NEITHER A DEFECT NOR A MALFUNCTION COULD BE DETECTED. ALL EXAMINATIONS REVEALED NO ABNORMALITIES. THE BLOOD PUMP MET ITS SPECIFICATIONS. THEREFORE, NO CORRELATION BETWEEN THE PUMP AND THE INCIDENT OF THE PATIENT COULD BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(6) WAS USED ON THE PATIENT FROM (B)(6) 2024 UNTIL THE TIME OF THE EVENT ON 2024-03-19 (4 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(6). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. THE SUPPORT WAS WITHDRAWN FROM THE PATIENT DUE TO POOR PROGNOSIS. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE PATIENT SUPPORT WAS WITHDRAWN 2 DAYS AFTER THE ADVERSE EVENT WAS REPORTED, HENCE BOX B2 HAS BEEN CORRECTED FROM DEATH TO LIFE THREATENING.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC. TO REPORT THAT THE PATIENT EXPERIENCED ACUTE NEUROLOGICAL CHANGES AND SUBSEQUENTLY SUFFERED A CARDIAC ARREST. DURING CPR, ONE OF THE NURSES NOTED AIR BUBBLES RESEMBLING FOAM IN THE PUMP. ON 3/21/24, THE SITE REPORTED THAT DURING THE EVENT, THE LEFT VENTRICLE HAD EMPTIED SIGNIFICANTLY AND THE PUMP WAS NOT FILLING, A DECISION WAS MADE TO DECREASE THE RATE ON THE IKUS DRIVER AND SUBSTITUTE VOLUME. THE AIR IN THE PUMP WAS NO LONGER VISIBLE, AND THE PUMP BEGAN FILLING COMPLETELY. THE SITE ALSO REPORTED THE PRESENCE OF AIR IN THE RIGHT HEART. IT WAS ALSO REPORTED THAT THE PATIENT HAD A LA LINE PLACED AT THE TIME OF THE IMPLANT. AFTER FURTHER DISCUSSION WITH THE SITE, THE SOURCE OF THE AIR COULD NOT BE DETERMINED. THE SITE ALSO REPORTED THAT THERE WAS NOTHING UNUSUAL WITH THE CANNULAS OR PUMP/MEMBRANE THAT COULD POTENTIALLY INTRODUCE AIR TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340862 BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Life Threatening| D