BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 15ML IN/OUT Ø 9MM

    MDR report key: 5441103 · Received February 17, 2016

    Report

    Report Number
    3004582654-2016-00005
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 26, 2016
    Report Date
    January 26, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 USED FROM (B)(6) 2015 TO (B)(6) 2016 (72 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. DURING INITIAL ANALYSIS, AN AIR CUSHION BETWEEN TWO LAYERS OF THE TRIPLE LAYERS WERE OBSERVED. THE PUMP WAS DISASSEMBLED AND A BUBBLE TEST WAS PERFORMED ON THE DRIVING MEMBRANES. A LEAK WAS LOCATED IN THE DRIVING MEMBRANE NEAR THE STABILIZATION RING. ABRASION WAS DETECTED BETWEEN TWO OF THE MEMBRANES AND ALSO OBSERVED GRAPHITE PARTICLES 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 DRIVING 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 INC. CLINICAL AFFAIRS ON (B)(6) 2016 TO REPORT THAT AN EXCOR BLOOD PUMP ON A PATIENT SUPPORTED IN LVAD CONFIGURATION HAD REDUCED EJECTION. THE SITE INCREASED THE SYSTOLIC PRESSURE AND % SYSTOLE SETTING ON THE DRIVING UNIT IN AN EFFORT TO IMPROVE EJECTION OF THE EXCOR BLOOD PUMP IN QUESTION. HOWEVER, WITH THIS MANEUVER THERE WAS NO IMPROVEMENT NOTED IN THE PUMP EJECTION. THE SITE THEN SWITCHED THE IKUS DRIVER TO THE BACKUP DRIVER IN ORDER TO RULE OUT ANY ISSUES WITH THE DRIVER. AFTER SWITCHING THE DRIVER THE PUMP STILL HAD REDUCED EJECTION. THE SITE SENT A VIDEO OF THE PUMP TO THE CLINICAL AFFAIRS TEAM FOR REVIEW. AFTER REVIEWING THE VIDEO AND DISCUSSION WITH SURGEON, CLINICAL AFFAIRS RECOMMENDED THAT THE SITE EXCHANGE THE EXCOR BLOOD PUMP IN QUESTION. THE SITE REPORTED THAT THE NEW PUMP HAD FULL FILL AND EJECTION AND THE PATIENT WAS AGAIN BEING SUPPORTED APPROPRIATELY BY THE EXCOR VAD SYSTEM AND DID NOT EXPERIENCE ANY UNTOWARD EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98426 EXCOR BLOOD PUMP PU VALVES 15ML IN/OUT Ø 9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO