BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM

    MDR report key: 7327239 · Received March 9, 2018

    Report

    Report Number
    3004582654-2018-00013
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 14, 2018
    Report Date
    March 9, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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) 2017 UNTIL (B)(6) 2018 (71 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 PUMP WAS RETURNED TO THE MANUFACTURER ON 2018-03-08. INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING AND A DETAILED REPORT WILL BE PROVIDED 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). DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP,PARTICLES WERE VISIBLE WITHIN THE AIR CHAMBER. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE AND MET ITS PERFORMANCE SPECIFICATION. NO UNUSUAL PUMPING SOUNDS WERE OBSERVED DURING OPERATION AND THE MEMBRANE WAS NOT IN CONTACT WITH THE PUMP HOUSING DURING END-SYSTOLE. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. BASED ON THE CT IMAGES, NO AIR CUSHIONS COULD BE DETECTED. HOWEVER,A MINIMAL AMOUNT OF PARTICLES WERE DETECTED IN THE MEMBRANE INTERSTICES. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. THREE LEAKS WERE DETECTED IN THE MIDDLE LAYER. GRAPHITE AGGLOMERATES WERE ALSO DETECTED IN THE MEMBRANE INTERSTICES. THE OTHER TWO LAYERS OF THE MEMBRANE WERE FOUND TO BE INTACT. AT THE TIME OF INVESTIGATION, THE THICKNESS OF EACH OF THE THREE LAYERS AT THE FIXED LOCATIONS AND IN THE REGION OF THE DEFECT WAS FOUND TO BE WITHIN SPECIFICATION. THE PUMPING SOUND WAS ASSESSED AS NORMAL. PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP SINCE THEY ARE MANUFACTURED BY A MANUAL PROCESS. IN 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. WHEN THE PUMP IS IN USE BY A PATIENT,A SMALL AMOUNT OF GRAPHITE PARTICLES MAY BE RELEASED FROM THE OUTER SURFACE OF THE AIR-SIDE LAYER. THE CAUSE OF THE DEFECT IN THE MIDDLE LAYER WAS MOST LIKELY DUE TO THE PARTICLES THAT FORMED DUE TO THE ABRASION BETWEEN THE LAYERS CAUSING INCREASED FRICTION AT SOME POINTS, WHICH FINALLY LED TO THE DEFECT IN THE MIDDLE LAYER. THIS DEFECT IN THE MIDDLE LAYER CAN AFFECT THE PUMPING BEHAVIOR AND MOVEMENT OF THE MEMBRANE, GIVING THE IMPRESSION OF MEMBRANE CONTACT WITH THE HOUSING DURING END SYSTOLE. THIS ALTERED MOVEMENT WAS NOTED BY THE CLINIC DURING ROUTINE EXAMINATION AND THE PUMP EXCHANGED. THE BLOOD PUMP CONTINUED TO FILL AND EMPTY FULLY AS INTENDED.

    Description of Event or Problem · 0

    BERLIN HEART GMBH WAS INFORMED BY THE CLINIC THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WAS EMITTING A STRANGE SOUND. DEBRIS WAS ALSO NOTED IN THE AIR CHAMBER OF THE BLOOD PUMP. ADDITIONALLY, THE BLOOD-SIDE LAYER OF THE MEMBRANE APPEARED TO BE IN CONTACT WITH THE PUMP HOUSING DURING SYSTOLE. THE CLINIC PROVIDED BERLIN HEART CLINICAL AFFAIRS (CA) WITH A VIDEO OF THE EVENT. AFTER EVALUATION OF THE VIDEO, BERLIN HEART RECOMMENDED AN IMMEDIATE EXCHANGE OF THE AFFECTED EXCOR BLOOD PUMP. THE REPLACEMENT OF THE BLOOD PUMP WAS WITHOUT COMPLICATIONS AND THE PATIENT REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169462 EXCOR BLOOD PUMP PU VALVES, 15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR