BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø12 MM

    MDR report key: 8575748 · Received May 2, 2019

    Report

    Report Number
    3004582654-2019-00032
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 4, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    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) 2018 UNTIL (B)(6) 2019 (107 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 CURRENTLY ONGOING. A DETAILED REPORT WILL BE SUBMITTED AS SOON AS AVAILABLE.

    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 CUSTOMER COMPLAINT WAS CONFIRMED, AFTER THE PUMP WAS RETURNED TO BERLIN HEART FOLLOWING THE EXCHANGE. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, A FEW LOOSE GRAPHITE PARTICLES WERE DETECTED IN THE AIR CHAMBER. DURING FUNCTIONAL TESTING, PUMPING SOUNDS COULD BE HEARD, SIMILAR TO THOSE NOTED IN THE VIDEO FROM THE CLINIC. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. ALL THREE MEMBRANE LAYERS LAY PARALLEL TO ONE ANOTHER. NO PARTICLES WERE DETECTED BETWEEN THE MEMBRANE LAYERS NOR ABNORMALITIES IN ANY OF THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY INSPECTED. A LEAK WAS DETECTED IN THE AIR-SIDE LAYER, LOCATED ALONG THE ROLLING RADIUS OF THE STABILIZATION RING. THE OTHER TWO LAYERS WERE FOUND TO BE INTACT. MINIMAL GRAPHITE AGGLOMERATES WERE NOTED BETWEEN THE MEMBRANES. THE THICKNESS OF THE INDIVIDUAL MEMBRANE LAYERS OF THE RETURNED BLOOD PUMP WAS RE-MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION AT ALL THE FIXED MEASUREMENT POINTS INCLUDING AT THE LEAKAGE REGION. THE CAUSE OF THE DEFECT IN THE AIR-SIDE LAYER 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 AND CAUSED THE IKUS ALARMS NOTICED BY THE CUSTOMER. DURING OPERATION OF BLOOD PUMPS, PUMPING SOUNDS CAN BE HEARD. PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP AND GET LOUDER OVER TIME. HOWEVER, IN THIS CASE, THE PUMPING SOUND IS CONSIDERED UNUSUAL IN COMPARISON TO OTHER PUMPS. WE WERE UNABLE TO DETERMINE THE EXACT CAUSE FOR THE UNUSUAL SOUND. 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.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS CONTACTED BY THE CLINIC TO REPORT THE PRESENCE OF GRAPHITE AGGLOMERATES IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION AND AN UNUSUAL CRUNCHING SOUND DURING PUMPING. THE CLINIC PROVIDED IMAGE AND VIDEO MATERIAL OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. AFTER REVIEWING THE PHOTOS AND VIDEOS, THE MANUFACTURER OF THE PUMP, BERLIN HEART (B)(4), 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 WAS NOT AFFECTED BY IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365697 EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø12 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR