BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7251828 · Received February 8, 2018

    Report

    Report Number
    3004582654-2018-00004
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 15, 2018
    Report Date
    February 8, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 (48 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. INITIAL VISUAL INVESTIGATION OF THE RETURNED PUMP INDICATES A DEFECTIVE AIR-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. A DETAILED INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING.

    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). DURING INITIAL ANALYSIS, AN AIR CUSHION WAS OBSERVED BETWEEN THE AIR-SIDE AND MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE. FUNCTIONAL TESTING INDICATED THAT THE PUMP DID NOT MEET ITS REQUIRED SPECIFICATION. THE PUMP WAS DISASSEMBLED FOR EVALUATION AND A LEAK WAS DETECTED IN THE AIR-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. THE OTHER TWO LAYERS DISPLAYED NO DEFECTS. THE CAUSE OF THE FAILURE WAS MOST LIKELY THE DIMINISHED GRAPHITE COATING. THE GRAPHITE PARTICLES THAT FORMED DUE TO THE ABRASION BETWEEN THE MEMBRANE LAYERS MOST LIKELY CAUSED INCREASED FRICTION AT CERTAIN POINTS WHICH FINALLY LED TO THE DEFECT IN THE AIR-SIDE LAYER OF THE MEMBRANE. WHEN THIS DEFECT OCCURS, AIR CAN GET BETWEEN THE MEMBRANE LAYERS AND FORM AN AIR CUSHION, WHICH REDUCES THE PUMP PERFORMANCE.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ON (B)(6) 2018 THAT THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION WAS NO LONGER COMPLETELY EMPTYING. AN ADJUSTMENT OF THE IKUS PARAMETERS DID NOT IMPROVE THE PUMP BEHAVIOR. THE CLINIC PROVIDED BERLIN HEART INC. A VIDEO OF THE EVENT. AFTER EVALUATION OF THE VIDEO, BERLIN HEART INC. RECOMMENDED AN IMMEDIATELY EXCHANGE OF THE AFFECTED EXCOR BLOOD PUMP DUE TO A SUSPECTED MEMBRANE DEFECT. THE AFFECTED RIGHT EXCOR BLOOD PUMP WAS EXCHANGED BY TRAINED PERSONNEL IN THE CLINIC. 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
    97429 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