BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6MM

    MDR report key: 5952883 · Received September 15, 2016

    Report

    Report Number
    3004582654-2016-00031
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 17, 2016
    Report Date
    August 18, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    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 MALFUNCTION WAS DETECTED ON THE DAY OF IMPLANTATION, ON (B)(6) 2016. THE EXCOR BLOOD PUMP, S/N (B)(4) WAS IN USE FOR LESS THAN ONE DAY. 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. THE BLOOD PUMP WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A PRELIMINARY VISUAL INSPECTION OF THE PRODUCT INDICATES A DEFECT OF THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. EVALUATION OF THE BLOOD PUMP IS 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). THE EXCOR BLOOD PUMP, S/N (B)(4) THAT IS THE SUBJECT OF THIS REPORT, WAS EVALUATED BY THE MANUFACTURER OF THE PUMP, BERLIN HEART (B)(4). DURING INITIAL ANALYSIS, A DARK BROWN RESIDUE WAS VISIBLE BETWEEN THE MEMBRANE INTERSTICES. THIS COULD HAVE LED TO THE SUSPICION OF A DEFECTIVE BLOOD SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. THE BLOOD PUMP WAS DISASSEMBLED FOR FURTHER ANALYSIS AND TESTED FOR LEAKAGES ON THE AIRSIDE, MIDDLE AND BLOOD-SIDE LAYERS OF THE TRIPLE LAYER MEMBRANE USING BUBBLE TESTING. DURING THE FAILURE INVESTIGATION, A DEFECT OF THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE OF THE EXCOR BLOOD PUMP WAS DETECTED. THIS DEFECT OF THE BLOOD-SIDE MEMBRANE WAS CONFIRMED THROUGH A BUBBLE TEST. THE DEFECT WAS LOCATED DIRECTLY OPPOSITE THE DE-AIRING PORT AND CORRESPONDED IN APPEARANCE TO THE SHAPE AND SIZE OF THE TIP OF THE DE-AIRING CANNULA. FURTHERMORE, THE AIRSIDE LAYER AND MIDDLE LAYER DISPLAYED A DEFECT AT THE SAME POINT. MOST LIKELY, THE BLOOD MEMBRANE WAS PUNCTURED DURING THE DE-AIRING OF THE BLOOD PUMP.

    Description of Event or Problem · 0

    BERLIN HEART (B)(4) WAS CONTACTED BY OUR (B)(4) DISTRIBUTOR, VIA EMAIL, TO REPORT THAT A BERLIN HEART PATIENT SUPPORTED IN THE LVAD CONFIGURATION EXPERIENCED INCOMPLETE EMPTYING OF THE EXCOR BLOOD PUMP. THE CLINIC SUSPECTED A DEFECTIVE MEMBRANE AND CONTACTED THE DISTRIBUTOR WHO RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. TRAINED PERSONNEL AT THE CLINIC REPLACED THE AFFECTED EXCOR BLOOD PUMP. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE EXCHANGE OF THE BLOOD PUMP WITH NO UNTOWARD EFFECT. THE PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605780 EXCOR BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6MM EXCOR BLOOD PUMP PU, 10 ML DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO