BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM

    MDR report key: 4241313 · Received November 10, 2014

    Report

    Report Number
    3004582654-2014-00044
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BLOOD PUMP WAS EVALUATED BY THE MANUFACTURER, (B)(4) HEART GMBH. VISUAL INSPECTION SHOWS PADDING (AIR CUSHION) BETWEEN 2 LAYERS OF THE TRIPLE LAYER MEMBRANES. A VIDEO PROVIDED BY THE SITE CONFIRMED THE SITE'S REPORTED OBSERVATION THAT THE BLOOD MEMBRANE APPEARS TO BE TOUCHING THE INNER SURFACE OF THE PUMP HOUSING. FURTHER EVALUATION BY THE MANUFACTURER OF THE DISASSEMBLED PUMP REVEALED A HOLE IN THE DRIVING MEMBRANE AND THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE, BEHIND THE STABILIZATION RING AT THE ROLLING RADIUS AND ALSO GRAPHITE PARTICLES BETWEEN THE MEMBRANES BEHIND THE STABILIZATION RING WHERE THE MEMBRANES AND THE REINFORCEMENT RING ARE GLUED TOGETHER. THE FORMATION OF GRAPHITE PARTICLES IN THE MEMBRANE INTERSTICES MAY HAVE BEEN CAUSED BY THE ABRASION OF THE MEMBRANES OVER TIME. THESE GRAPHITE PARTICLES BETWEEN THE MEMBRANE LAYERS MOST LIKELY CAUSED INCREASED FRICTION AT CERTAIN POINTS WHICH FINALLY LED TO THE DEFECT IN THE DRIVING MEMBRANE AND THE MIDDLE LAYER OF THE MEMBRANES. WHEN THIS DEFECT OCCURS, AIR CAN GET BETWEEN THE MEMBRANE LAYERS AND FORM AN AIR CUSHION. THE BLOOD MEMBRANE WAS STRETCHED BY THE AIR CUSHION IN THE SYSTOLIC PHASE, WHICH MAY HAVE ALLOWED THIS LAYER OF THE MEMBRANE TO TOUCH THE INNER SURFACE OF THE PUMP HOUSING. THIS IS CONFIRMED IN THE VIDEO PROVIDED BY THE SITE. THE CAUSE OF THE DIMINISHED PERFORMANCE OF THE BLOOD PUMP IS THE DEFECT IN THE DRIVING MEMBRANE LAYER THAT RESULTED IN THE FORMATION OF AN AIR CUSHION. THE MANUFACTURER HAS IMPLEMENTED SOME CHANGES IN THE PRODUCTION PROCESS TO MITIGATE MEMBRANE LAYER DEFECTS AND HAS TRAINED PRODUCTION WORKERS TO OPTIMIZE THE AMOUNT OF GRAPHITE BETWEEN THE LAYERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXCOR BLOOD PUMP, S/N (B)(4), WAS USED FROM (B)(6) 2014 (87 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 INVESTIGATION OF THE RETURNED BLOOD PUMP A DEFECT OF THE AIR-SIDE LAYER OF THE TRIPLE-LAYER MEMBRANE WAS SUSPECTED. HOWEVER, EVALUATION OF THE BLOOD PUMP S/N (B)(4) IS STILL ONGOING.

    Description of Event or Problem · 1

    BERLIN HEART (B)(4) WAS INFORMED BY THE DISTRIBUTOR THAT THE CLINIC CONTACTED THE DISTRIBUTOR TO INQUIRE A NOISE COMING FROM THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE CLINIC DESCRIBED THE NOISE AS SQUEALING "LIKE A LITTLE CAT." FURTHERMORE THE CLINIC REPORTED THAT THE MEMBRANE OF THE EXCOR BLOOD PUMP LOOKS LIKE IT IS TOUCHING THE INNER SURFACE OF THE HOUSING WHEN THE MEMBRANE IS IN ITS SYSTOLIC END POSITION. THE DEVICE CONTINUED TO WORK AS INTENDED AND SUPPORTED THE PATIENT WITHOUT INCIDENT. A VIDEO FILE WAS SENT TO BERLIN HEART (B)(4), ON WHICH THE CLINIC'S OBSERVATION REGARDING THE TOUCHING OF THE MEMBRANE WITH THE INNER SURFACE OF THE HOUSING COULD BE CONFIRMED. THE CLINIC EXCHANGED THE EXCOR BLOOD PUMP IN QUESTION IMMEDIATELY. BERLIN HEART (B)(4) WAS INFORMED THAT EXCHANGE OF THE EXCOR BLOOD PUMP WAS UNEVENTFUL AND THE PATIENT IS DOING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724207 EXCOR BLOOD PUMP PU VALVES 30 ML, IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR