BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8679282 · Received June 7, 2019

    Report

    Report Number
    3004582654-2019-00055
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT WAS CONFIRMED. INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP COULD NOT IDENTIFY ANY DEFECTS. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT MET ITS REQUIRED PUMPING SPECIFICATION. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY EXAMINED. ALL THREE MEMBRANE LAYERS WERE FOUND TO BE INTACT. GRAPHITE AGGLOMERATES WERE DETECTED BETWEEN THE MEMBRANES. THESE COULD BE SEEN AS BUMPS ON THE MEMBRANE SURFACE, CONFIRMING THE CUSTOMER COMPLAINT. NO MEMBRANE DEFECT COULD BE DETECTED. THE CAUSE OF THE BUMPS NOTED ON THE MEMBRANE WAS MOST LIKELY THE GRAPHITE PARTICLES THAT FORMED DUE TO AN ABRASION BETWEEN THE LAYERS. THE RESULTING GRAPHITE AGGLOMERATES LED TO A RECURRING OPTICAL ABNORMALITY.

    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 2019-03-04 UNTIL 2019-05-17(74 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 THE MANUFACTURER YET. A DETAILED REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ANALYSIS. THIS REPORT INVOLVES THE RIGHT EXCOR BLOOD PUMP OF THE PATIENT. THE LEFT SIDE PUMP (SERIAL NUMBER (B)(4)) WILL BE REPORTED UNDER 3004582654-2019-00054.

    Description of Event or Problem · 0

    BERLIN (B)(4) WAS CONTACTED BY THE CLINIC TO REPORT DIMPLES NOTED ON THE AIR-SIDE MEMBRANE OF BOTH THE EXCOR BLOOD PUMPS OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. THE CLINIC THEN PROVIDED BERLIN HEART CA PERSONNEL WITH VIDEO MATERIAL OF THE AFFECTED BLOOD PUMPS AT THE TIME OF THE INCIDENT. UPON EVALUATION,AN ELECTIVE EXCHANGE OF THE AFFECTED BLOOD PUMPS WAS RECOMMENDED. TRAINED PERSONNEL AT THE CLINIC EXCHANGED THE BLOOD PUMP ON (B)(6) 2019 WITHOUT INCIDENCE. THE PATIENT WAS NOT AFFECTED BY THIS INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473991 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 4 YR