BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 6349593 · Received February 22, 2017

    Report

    Report Number
    3004582654-2017-00006
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    February 4, 2017
    Report Date
    February 21, 2017
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE PATIENT REMAINS ON SUPPORT AND IS DOING WELL. BLOOD PUMPS WERE CHANGED AT THE TIME OF SURGICAL INTERVENTION AS PRECAUTION, NOT BECAUSE OF ANY DEFECT OF THE PUMPS.

    Description of Event or Problem · 0

    BERLIN HEART INC. CLINICAL AFFAIRS (CA) CONTACTED THE SITE ON FEBRUARY 7, 2017 TO FOLLOW UP ON A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. THE SITE REPORTED THAT THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) FOR CHEST EXPLORATION FOR SUSPECTED INFECTION. THE AORTIC ANASTOMOSIS SITE APPEARED INFECTED AND THE ARTERIAL CANNULA WAS REMOVED AND REPLACED. BOTH BLOOD PUMPS WERE REPLACED DURING THIS PROCEDURE. THERE WERE REPORTEDLY NO CHANGES TO THE PUMP FUNCTION DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131536 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Life Threatening