BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 12016860 · Received June 17, 2021

    Report

    Report Number
    3004582654-2021-00032
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP, 2020475, WAS IN USE FROM (B)(6) 2021 TO (B)(6) 2021 (14 DAYS). THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2021 AND HAD MULTIPLE PUMP EXCHANGES DUE TO DEPOSITS IN THE PUMP.

    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 WHO HAS ALCAPA SUFFERED FROM TWO HEMORRHAGIC CVAS. THE PATIENT IS NOW UNDER PALLIATIVE CARE. WE GOT NO DETAILED INFORMATION ABOUT THE CIRCUMSTANCES OF THIS CASE. THE PATIENT HAD SUBDURAL BLEEDING WITH CONSECUTIVE PARENCHYMAL BLEEDING AND DIED ON (B)(6) 2021. THE DEVICE PERFORMED AS INTENDED AT THE TIME OF THE EVENT. HOWEVER, THERE WERE DEPOSITS SEEN IN THE BLOOD CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913320 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death| L