BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8575749 · Received May 2, 2019

    Report

    Report Number
    3004582654-2019-00033
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 9, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 EXCOR BLOOD PUMP, S/N: (B)(4), WAS IN USE BY THE PATIENT FROM (B)(6) 2019 UNTIL (B)(6) 2019 (51 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 AS SOON AS AVAILABLE.

    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 TO BERLIN HEART INC. WAS CONTACTED BY THE CLINIC TO REPORT AN UNUSUAL PUMPING SOUND AND MEMBRANE MOVEMENT IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION.' CORRECTED INFORMATION: BERLIN HEART INC. WAS CONTACTED BY THE CLINIC TO REPORT AN UNUSUAL PUMPING SOUND AND BUMPS ON THE MEMBRANE OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC PROVIDED VIDEOS AND IMAGES OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT BASED ON WHICH THE COMPLAINT CAN BE CONFIRMED. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE.NO DEFECTS WERE DETECTED DURING INITIAL VISUAL INSPECTION OF THE RETURNED BLOOD PUMP. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT MET ITS REQUIRED PUMPING SPECIFICATION. PUMPING SOUNDS WERE CONFIRMED DURING THE TEST BUT NOT UNUSUAL. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. ALL THREE MEMBRANE LAYERS WERE INTACT. GRAPHITE AGGLOMERATES DETECTED BETWEEN THE MEMBRANES. THESE COULD BE SEEN AS BUMPS ON THE MEMBRANE SURFACE,CONFIRMING THE CUSTOMER COMPLAINT. HOWEVER NO MEMBRANE DEFECT WAS DETECTED. THE THICKNESS OF THE INDIVIDUAL MEMBRANE LAYERS OF THE RETURNED BLOOD PUMP WAS RE-MEASURED AT FIXED POINTS AND FOUND TO BE WITHIN AT ALL THE FIXED LOCATIONS. THE BUMPS SEEN ON MEMBRANE, MOST PROBABLY THE GRAPHITE PARTICLES CREATED BY ABRASION BETWEEN THE MEMBRANES. THE RESULTING GRAPHITE AGGLOMERATES LED TO A LOCAL OPTICAL ABNORMALITY. DURING PUMP OPERATION, PUMPING NOISES COULD BE HEARD FROM THE BLOOD PUMP. PUMP SOUNDS CAN VARY FROM PUMP TO PUMP AND GET LOUDER OVER TIME. IN THIS CASE, THEY WERE NOT UNUSUAL IN COMPARISON TO OTHER PUMPS.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE CLINIC TO REPORT AN UNUSUAL PUMPING SOUND AND MEMBRANE MOVEMENT IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. A SMALL QUANTITY OF GRAPHITE WAS ALSO NOTED IN THE AIR CHAMBER. THE CLINIC PROVIDED IMAGE AND VIDEO MATERIAL OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. VIDEO MATERIAL FROM THE CLINIC WAS EVALUATED BY BERLIN HEART (B)(4) AND AN EXCHANGE OF THE AFFECTED BLOOD PUMP WAS RECOMMENDED DUE TO DIMPLES VISIBLE ON THE MEMBRANE. THE PUMP FUNCTION WAS NOT AFFECTED AND CONTINUED TO FILL AND EMPTY COMPLETELY. THE AFFECTED PUMP WAS EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WAS NOT AFFECTED BY IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365701 EXCOR BLOOD PUMP PU VALVES,25 ML IN/OUT Ø12 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR