BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8053044 · Received November 8, 2018

    Report

    Report Number
    3004582654-2018-00056
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 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
    MD, 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) 2018 UNTIL (B)(6) 2018 (91 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. THE AFFECTED BLOOD PUMP HAS NOT BEEN RETURNED TO US AT THIS TIME. A DETAILED REPORT OF THE RETURNED PUMP WILL BE SUBMITTED AS SOON AS AVAILABLE.

    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 PUMP WAS RETURNED TO BERLIN HEART ON (B)(6) 2018. THE INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP CONFIRMED THE CUSTOMER COMPLAINT. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE AND MET ITS REQUIRED PERFORMANCE SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. ALL THREE LAYERS OF THE TRIPLE LAYER MEMBRANE LAY PARALLEL TO ONE ANOTHER. SEVERAL LEAKS WERE DETECTED IN THE MIDDLE LAYER. PARTICLES WERE DETECTED BETWEEN THE MEMBRANES. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED. MULTIPLE LEAKS WERE DETECTED IN THE MIDDLE LAYER OF THE TRIPLE LAYER MEMBRANE. A SMALL AMOUNT OF GRAPHITE AND PU MATERIAL WAS CONFIRMED BETWEEN THE MEMBRANES. THE OTHER TWO LAYERS OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. FRICTION MARKS WERE OBSERVED ON ALL THE MEMBRANE LAYERS. AT THE TIME OF INVESTIGATION, THE MEMBRANE THICKNESS WAS FOUND TO BE WITHIN SPECIFICATION AT THE FIXED LOCATIONS IN ALL THREE LAYERS. MEASUREMENTS IN THE AREA OF THE LEAKAGES INDICATE THAT THE THICKNESS PROFILE OF THE MIDDLE LAYER WAS NOT HOMOGENEOUS. THE CAUSE OF THE FAILURE WAS MOST LIKELY THE GRAPHITE PARTICLES THAT FORMED DUE TO AN ABRASION BETWEEN THE LAYERS. THIS CAUSED INCREASED FRICTION AT POINTS, WHICH FINALLY LED TO THE DEFECT IN THE MIDDLE LAYER.

    Description of Event or Problem · 0

    THE CLINIC INITIALLY CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) ON (B)(6) 2018 TO REPORT THAT A MINIMAL AMOUNT OF GRAPHITE PARTICLES WERE NOTED IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC REPORTED THAT THE PUMP FUNCTION WAS NOT AFFECTED. BERLIN HEART INC. ADVISED THE CLINIC TO KEEP THE AFFECTED BLOOD PUMP UNDER STRICT OBSERVATION AND CONTACT BERLIN HEART IF FURTHER ACCUMULATION OCCURRED. ON (B)(6) 2018, CA PERSONNEL RECEIVED A PICTURE OF THE BLOOD PUMP WITH AN INCREASED AMOUNT OF GRAPHITE IN THE AIR CHAMBER AND RECOMMENDED AN EXCHANGE OF THE BLOOD PUMP. THE BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891159 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 8 MO