BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM

    MDR report key: 8664241 · Received June 3, 2019

    Report

    Report Number
    3004582654-2019-00052
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 10, 2019
    Report Date
    June 3, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: 3008454189) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH(MANUFACTURER). THE CLINIC PROVIDED BERLIN HEART WITH VIDEOS OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. BASED ON THESE, AN INCOMPLETE EJECTION OF THE BLOOD PUMP COULD BE CONFIRMED. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP,AN AIR CUSHION WAS DETECTED BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. A LEAK WAS DETECTED IN THE AIR-SIDE LAYER LOCATED AT THE EDGE REGION ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. FURTHERMORE, GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANE INTERSTICES. THE MIDDLE AND BLOOD-SIDE LAYERS OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS WAS RE-MEASURED AND FOUND TO BE WITHIN SPECIFICATION INCLUDING AT THE REGION OF THE DEFECT. THE CAUSE OF THE DEFECT 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 LAYER OF THE TRIPLE-LAYER MEMBRANE. AS A RESULT OF THIS DEFECT, AIR GOT IN AND FORMED AN AIR CUSHION IN THE MEMBRANE INTERSTICES, CAUSING THE REDUCED PUMP PERFORMANCE (INCOMPLETE FILLING AND EMPTYING).

    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) 2019 UNTIL (B)(6) 2019(65 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 PUMP HAS NOT BEEN RETURNED TO THE MANUFACTURER YET. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART (B)(4) WAS INFORMED BY THE ARGENTINIAN DISTRIBUTOR OF INCOMPLETE EMPTYING SUSPECTED IN THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. AN ADJUSTMENT OF THE PARAMETERS ON THE STATIONARY DRIVING UNIT IKUS DID NOT IMPROVE THE SITUATION AND THE CLINIC DECIDED TO EXCHANGE THE AFFECTED BLOOD PUMP. THE PATIENT RECEIVED AN ORGAN DONATION ON THE SAME DAY AND WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455396 EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR