BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3915308 · Received May 27, 2014

    Report

    Report Number
    3004582654-2014-00022
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 (272 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. INITIAL INVESTIGATION OF THE RETURNED BLOOD PUMP CONFIRMED A DEFECT OF THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. THE EVALUATION OF THE BLOOD PUMP S/N (B)(4) IS STILL ONGOING. THE CAUSE OF THE DEFECT IN THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE HAS NOT YET BEEN DETERMINED.

    Description of Event or Problem · 1

    BERLIN HEART (B)(4) WAS INFORMED BY THE SITE THAT BLOOD WAS DETECTED AROUND THE STABILIZATION RING IN THE BLOOD PUMP IN A PATIENT SUPPORTED IN A LVAD CONFIGURATION. NO CHANGES IN PATIENT HEMODYNAMICS OR PUMP FUNCTION WERE REPORTED, AND THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EVENTS AS A RESULT OF THE INCIDENT OR THE BLOOD PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311509 EXCOR BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM DSQ: VENTRICULAR ASSISTED DEVICE DSQ BERLIN HEART GMBH P30P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR