BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM

    MDR report key: 7465127 · Received April 26, 2018

    Report

    Report Number
    3004582654-2018-00020
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    April 6, 2018
    Report Date
    April 26, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 EXCOR BLOOD PUMP, S/N (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2017 UNTIL (B)(6) 2018 (147 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. 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. EVALUATION OF THE AFFECTED BLOOD PUMP STILL ON GOING, DETAIL ANALYSIS WILL BE PROVIDED AS SOON AS FINDINGS ARE AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ON (B)(6) 2018 THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WAS NO LONGER COMPLETELY EJECTING. THE CLINIC PROVIDED BERLIN HEART INC. A VIDEO OF THE EVENT. AFTER EVALUATION OF THE VIDEO, BERLIN HEART INC. RECOMMENDED AN IMMEDIATE EXCHANGE OF THE AFFECTED EXCOR BLOOD PUMP. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307371 EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR