BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM

    MDR report key: 11716745 · Received April 23, 2021

    Report

    Report Number
    3004582654-2021-00025
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3 SHOULD BE (B)(6) 2021, NOT (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2020 UNTIL (B)(6) 2021 (410 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 1

    WE WERE INFORMED BY THE CLINIC THAT A PATIENT THAT WAS IMPLANTED IN THE LVAD CONFIGURATION HAD AN ADVERSE EVENT ON (B)(6) 2021. THE CLINIC REPORTED THAT THE PATIENT DEVELOPED HEMOLYSIS. ADDITIONALLY, THE CLINIC REPORTED A SQUEAKING VALVE. IT WAS REPORTED THAT THE PATIENT BECAME JAUNDICE AS THE BILIRUBIN LEVELS INCREASED. IT WAS ALSO REPORTED THAT THE HEMOGLOBIN WAS 8. THE BLOOD PUMP WAS USED FOR MORE THAN 400 DAYS AGAINST OUR RECOMMENDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609471 BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other