BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø12 MM

    MDR report key: 8641478 · Received May 24, 2019

    Report

    Report Number
    3004582654-2019-00045
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 CUSTOMER COMPLAINT WAS CONFIRMED FROM VIDEOS FROM THE SITE. INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP COULD NOT IDENTIFY ANY DEFECTS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY EXAMINED. ALL THREE MEMBRANE LAYERS WERE INTACT. LOOSE GRAPHITE WAS DETECTED BETWEEN THE MEMBRANES. THE THICKNESS OF THE INDIVIDUAL MEMBRANE LAYERS OF THE RETURNED BLOOD PUMP WAS RE-MEASURED AT FIXED POINTS. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS WAS FOUND TO BE WITHIN SPECIFICATION. DURING PUMP OPERATION, PUMPING NOISES COULD BE HEARD FROM THE BLOOD PUMP. HOWEVER, THESE WERE NOT UNUSUAL COMPARED TO OTHER PUMPS. PUMP SOUNDS CAN VARY FROM PUMP TO PUMP AND ARE NOT UNUSUAL OR NOTICEABLE IN THIS CASE. THE ABNORMALITY REPORTED BY THE CUSTOMER WAS LOOSE GRAPHITE. DURING THE PRODUCTION OF 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 PUMPING FUNCTION WHEN IN USE ON THE PATIENT, A SMALL AMOUNT OF GRAPHITE PARTICLES MAY DETACH FROM THE OUTER SURFACE OF THE AIR-SIDE LAYER. SINCE THE GRAPHITE PARTICLES ARE LOOSE, THEY CAN CHANGE THEIR POSITION DURING TRANSPORT OR FURTHER HANDLING. THEREFORE THIS ANOMALY COULD NOT BE DUPLICATED. SINCE THE ABNORMALITY LED TO UNCERTAINTY FOR THE CUSTOMER, WE RECOMMENDED AN 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 UNTIL (B)(6) 2019 (28 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 RETURNED PUMP IS ONGOING AND A DETAILED REPORT WILL BE SUBMITTED AS SOON AS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE CLINIC TO REPORT AN UNUSUAL PUMPING SOUND IN THE AIR CHAMBER OF AN EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. SITE ALSO NOTED GRAPHITE PARTICLES IN THE AIR CHAMBER ON THE PUMP HOUSING. THE CLINIC PROVIDED IMAGE AND VIDEO MATERIAL OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. UPON EVALUATION, BERLIN HEART RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. THE AFFECTED PUMP WAS EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433260 EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø12 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO