BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4096910 · Received July 24, 2014

    Report

    Report Number
    3004582654-2014-00033
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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), 2014 (84 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION 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 BLOOD PUMP WAS RETURNED TO THE MANUFACTURER. PRELIMINARY ANALYSIS CONFIRMED THE SITES FINDINGS. THE EVALUATION OF THE BLOOD PUMP S/N (B)(4) IS STILL ONGOING. THE CAUSE OF THE DEFECT HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED BY THE SITE, THAT BLOOD WAS DETECTED IN FRONT OF THE STABILIZATION RING IN BETWEEN TWO LAYERS OF THE TRIPLE LAYER MEMBRANE OF THE EXCOR BLOOD PUMP IN THE RVAD POSITION ON A PATIENT SUPPORTED WITH BIVAD. THE SITE DECIDED TO EXCHANGE THE BLOOD PUMP DUE TO A SUSPECTED DEFECT OF ONE LAYER OF THE TRIPLE LAYER MEMBRANE. PATIENT TOLERATED THE EXCHANGE OF THE BLOOD PUMP WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433318 EXCOR BLOOD PUMP PU VALVES 25 ML, IN/OUT 9 MM VENTRICULAR ASSISTED DEVICE "DSQ" DSQ BERLIN HEART GMBH P25P-001

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR