BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 30 ML IN/OUT Ø9 MM

    MDR report key: 7835057 · Received August 30, 2018

    Report

    Report Number
    3004582654-2018-00043
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    August 4, 2018
    Report Date
    August 30, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 (93 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. AN AIR CUSHION WAS DETECTED DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE AND DID NOT MEET ITS REQUIRED FUNCTIONAL PERFORMANCE. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION WHERE AN AIR CUSHION WAS CONFIRMED BETWEEN THE BLOOD-SIDE LAYER AND MIDDLE LAYERS. MINIMAL QUANTITY OF SMALL PARTICLES WERE VISIBLE BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED. A LEAK WAS DETECTED IN THE AIR-SIDE LAYER ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. A LEAK WAS DETECTED IN THE MIDDLE LAYER, CLOSE TO THE CENTER. FURTHERMORE, GRAPHITE AGGLOMERATES WERE FOUND BETWEEN THE MEMBRANES. THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE WAS FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE MEMBRANE THICKNESS WAS FOUND TO BE WITHIN SPECIFICATION FOR ALL THE THREE LAYERS INCLUDING AT THE DEFECT REGIONS. 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 AIR-SIDE AND MIDDLE LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    Description of Event or Problem · 0

    WE WERE INFORMED BY THE CLINIC THAT A MEMBRANE DEFECT WAS SUSPECTED IN THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. THE AFFECTED BLOOD PUMP WAS IMMEDIATELY EXCHANGED BY EXPERIENCED PERSONNEL AT THE CLINIC. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676513 EXCOR BLOOD PUMP PU VALVES, 30 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR