BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT 6MM

    MDR report key: 3931198 · Received June 3, 2014

    Report

    Report Number
    3004582654-2014-00024
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART (B)(4) (MFR). THE EXCOR BLOOD PUMP, S/N (B)(4), WAS USED FROM (B)(6) 2014 (86 DAYS). THIS PUMP WAS COLLECTED FROM THE SITE AND RETURNED TO THE MFR FOR EVAL. WE HAVE REPORTED 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-SITE 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

    SITE CALLED BERLIN HEART CLINICAL AFFAIRS TO REPORT THAT THE LVAD ON THE PT SUPPORTED IN BVAD CONFIGURATION WAS NOT EJECTING FULLY. RVAD WAS FUNCTIONING APPROPRIATELY. A VIDEO CLIP SENT BY THE SITE CONFIRMED THE CLINICS' OBSERVATION. THE SITE WAS INSTRUCTED TO ADJUST THE PARAMETERS OF THE DRIVING UNIT IKUS. ADJUSTMENT OF THE PARAMETERS DID NOT IMPROVE THE LVAD EJECTION. THE PT WAS CALM AND NOT MOVING AND THE CANNULA WERE NOT KINKED. THE SITE REPORTED THAT THE PUMP APPEARS TO HAVE PADDING OR A PILLOW LIKE APPEARANCE IN BETWEEN THE MEMBRANE LAYERS. SITE WAS INSTRUCTION TO EXCHANGE THE LVAD PUMP DUE TO A SUSPECTED MEMBRANE DEFECT. AFTER EXCHANGE OF THE PUMP, THE LVAD WAS EJECTING PROPERLY AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325735 EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT 6MM VENTRICULAR ASSISTED DEVICE DSQ BERLIN HEART GMBH P10P-001

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO