BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 25 ML, IN/OUT 9 MM

    MDR report key: 3922692 · Received June 16, 2014

    Report

    Report Number
    3004582654-2014-00027
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 18, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXCOR BLOOD PUMP, S/N (B)(4), WAS USED FROM (B)(6) 2013 TO (B)(6) 2014 (182 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N(B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPEC AND NO ABNORMALITIES WERE FOUND IN THE RECORDS. THE BLOOD PUMP IS DESIGNED WITH A TRIPLE LAYER MEMBRANE SEPARATING THE AIR CHAMBER FROM BLOOD CHAMBER FOR SAFETY REASONS. THE ENTIRE MEMBRANE CONSISTS OF AN AIR-SIDE LAYER, A MIDDLE LAYER AND A BLOOD-SIDE LAYER. IN CASE OF DISRUPTION IN ONE OF THE TRIPLE LAYERS, THERE ARE TWO MORE LAYERS THAT WILL MAINTAIN THE INTEGRITY OF THE AIR AND BLOOD CHAMBERS. THE INITIAL VISUAL INSPECTION OF THE DEVICE CONFIRMS THE SITES FINDINGS, HOWEVER, EVAL OF THE BLOOD PUMP S/N (B)(4) IS STILL ONGOING.

    Description of Event or Problem · 1

    BERLIN HEART (B)(4) WAS INFORMED BY OUR DISTRIBUTOR THAT BLOOD WAS OBSERVED IN FRONT OF THE STABILIZATION RING BETWEEN THE TWO LAYERS OF THE TRIPLE LAYER MEMBRANE IN THE EXCOR BLOOD PUMP IN A PT SUPPORTED IN A LVAD CONFIGURATION. THE SITE WAS INSTRUCTED TO EXCHANGE THE LVAD PUMP DUE TO A SUSPECTED DEFECT OF ONE LAYER OF THE MEMBRANE. NO CHANGES IN PUMP FUNCTION WERE REPORTED, AND THE PT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE BLOOD PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353028 EXCOR BLOOD PUMP PU VALVES 25 ML, IN/OUT 9 MM VENTRICULAR ASSITED DEVICE "DSQ" DSQ BERLIN HEART GMBH P25P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR