BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 25ML IN/OUT Ø9MM

    MDR report key: 5738129 · Received June 21, 2016

    Report

    Report Number
    3004582654-2016-00020
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    May 22, 2016
    Report Date
    May 23, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 USED FROM 03/30/2016 TO 05/22/2016(53 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(4).THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS. 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. DURING INITIAL ANALYSIS, AN AIR CUSHION BETWEEN TWO LAYERS OF THE TRIPLE LAYERS WAS OBSERVED. THE PUMP WAS DISASSEMBLED FOR EVALUATION AND A LEAK WAS LOCATED IN THE AIR-SIDE AND THE MIDDLE LAYER OF THE MEMBRANE, EACH. ADDITIONALLY,ABRASION WAS DETECTED BETWEEN TWO OF THE MEMBRANE LAYERS AND GRAPHITE PARTICLES WERE OBSERVED IN THE MEMBRANE INTERSTICES. 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 TRIPLE LAYER MEMBRANE. THE CAUSE OF THE FAILURE WAS MOST LIKELY THE DIMINISHED GRAPHITE COATING WHICH MAY HAVE RESULTED IN ABRASION OF THE MEMBRANE OVER TIME. WHEN THIS DEFECT OCCURS, AIR CAN GET BETWEEN THE MEMBRANE LAYERS AND FORM AN AIR CUSHION, WHICH REDUCED THE PUMP PERFORMANCE. THE MANUFACTURER HAS IMPLEMENTED SOME CHANGES IN THE PRODUCTION PROCESS TO MITIGATE MEMBRANE LAYER DEFECTS.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART (B)(4) TO INFORM THAT A BERLIN HEART EXCOR PATIENT SUPPORTED IN THE BIVAD CONFIGURATION, EXPERIENCED AN INSUFFICIENT PUMP PERFORMANCE OF THE RIGHT EXCOR BLOOD PUMP. THE CLINIC ADJUSTED THE STATIONARY DRIVING UNIT, IKUS PARAMETERS, BUT NO IMPROVEMENT WAS OBSERVED. CONSEQUENTLY, THE CLINIC DECIDED TO EXCHANGE THE RIGHT EXCOR BLOOD PUMP. THE EXCHANGE OF THE BLOOD PUMP WAS PERFORMED SUCCESSFULLY BY TRAINED STAFF IN THE CLINIC AND THE PATIENT DID NOT EXPERIENCE ANY UNTOWARD EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392765 EXCOR BLOOD PUMP PU VALVES, 25ML IN/OUT Ø9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR