BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8546864 · Received April 24, 2019

    Report

    Report Number
    3004582654-2019-00031
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    117

    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). A CORRECTION NEEDS TO BE MADE IN B5:'AFTER REVIEWING THE PHOTOS AND VIDEOS, THE MANUFACTURER OF THE PUMP, BERLIN HEART GMBH, RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP DUE TO UNUSUAL RING VISIBLE DURING THE MEMBRANE MOVEMENT'. CORRECTED INFORMATION: AFTER REVIEWING THE PHOTOS AND VIDEOS, MANUFACTURER OF THE PUMP, BERLIN HEART GMBH, RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP DUE TO AN UNUSUAL MEMBRANE MOVEMENT NOTED IN THE CLINIC'S VIDEO. THE CLINIC REPORTED GRAPHITE PARTICLES IN THE AIR CHAMBER OF AN EXCOR BLOOD PUMP AND PROVIDED BERLIN HEART WITH PHOTOS AND VIDEOS OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT WHERE SOME LOOSE GRAPHITE DUST WAS NOTED ON THE STABILIZATION RING IN THE AIR CHAMBER. IN THE VIDEOS, IT APPEARED THAT THE MEMBRANE MOVEMENT WAS UNUSUAL DESPITE COMPLETE FILLING AND EMPTYING. THEREFORE, THE MANUFACTURER RECOMMENDED AN EXCHANGE OF THE EXCOR BLOOD PUMP. THE BLOOD PUMP RAN FOR 19 DAYS. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. DURING INITIAL VISUAL INSPECTION OF THE RETUNED PUMP, THE GRAPHITE AGGLOMERATES IN THE AIR CHAMBER COULD NOT BE CONFIRMED DUE TO A HUMID PRECIPITATION IN THE AIR CHAMBER. THE CUSTOMER COMPLAINT COULD ONLY BE CONFIRMED BASED ON THE PROVIDED IMAGE. AN UNUSUAL MEMBRANE MOVEMENT COULD NOT BE CONFIRMED. 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 AND NO ABNORMALITIES WERE SEEN IN THE CT-SCANS OF THE LAYERS. NO PARTICLES WERE NOTED BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. THE LOOSE GRAPHITE DUST ON THE STABILIZATION RING IN THE AIR CHAMBER COULD NO LONGER BE FOUND. A FEW VERY SMALL GRAPHITE AGGLOMERATES (LESS THAN 0.2 MM) WERE FOUND BETWEEN THE MEMBRANES. ALL THREE LAYERS OF THE MEMBRANE WERE CONFIRMED TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS WAS FOUND TO BE WITHIN SPECIFICATION. NO DEFECTS COULD BE DETECTED. THE REASON FOR THE GRAPHITE AGGLOMERATES NOTED IN THE AIR CHAMBER IS MOST PROBABLY THE GRAPHITE PARTICLES LOOSENED BY FRICTION BETWEEN THE MEMBRANE AND THE STABILIZATION RING. SINCE THE AIR CHAMBER OF THE RETURNED PUMP SHOWED A DAMP PRECIPITATION, IT IS VERY LIKELY THAT THE LOOSE GRAPHITE PARTICLES SEEN ON ONE OF THE PHOTOS WERE ABSORBED AND WASHED AWAY FROM THE STABILIZATION RING DURING TRANSPORT. DURING THE PRODUCTION OF THE EXCOR BLOOD PUMPS, GRAPHITE POWDER IS APPLIED TO BOTH SURFACES OF THE AIR-SIDE AND MIDDLE LAYER, AS WELL AS TO THE INNER SURFACE OF THE BLOOD-SIDE LAYER OF THE MEMBRANE. DURING THE PUMPING FUNCTION WHEN USED ON THE PATIENT, A SMALL AMOUNT OF GRAPHITE PARTICLES CAN DETACH FROM THE OUTER SURFACE OF THE AIR-SIDE LAYER. THE SUSPECTED UNUSUAL MEMBRANE MOVEMENT NOTED IN THE VIDEO APPEARS TO HAVE BEEN AN OPTICAL ILLUSION. THE ABNORMALITY LED TO UNCERTAINTY FOR THE CUSTOMER AND WE RECOMMENDED A PUMP EXCHANGE.

    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 (19 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. INVESTIGATION OF THE AFFECTED BLOOD PUMP IS CURRENTLY ONGOING AND A DETAILED REPORT WILL BE SUBMITTED UPON COMPLETION OF THE ANALYSIS.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC THAT GRAPHITE AGGLOMERATES WERE NOTED IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC PROVIDED BERLIN HEART WITH PHOTOS AND VIDEOS OF THE BLOOD PUMP. AFTER REVIEWING THE PHOTOS AND VIDEOS, MANUFACTURER OF THE PUMP, BERLIN HEART (B)(4), RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP DUE TO UNUSUAL RING VISIBLE DURING THE MEMBRANE MOVEMENT. THE AFFECTED BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL ON (B)(6) 2019. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339779 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 22 MO