BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES,10 ML IN/OUT Ø6 MM

    MDR report key: 8336922 · Received February 13, 2019

    Report

    Report Number
    3004582654-2019-00012
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 13, 2019
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). THE AFFECTED BLOOD PUMP WAS EXCHANGED BY THE CLINIC DUE TO BUMPS ON THE MEMBRANE SURFACE AND AN UNUSUAL PUMPING SOUND. THE BLOOD PUMP RAN FOR 33 DAYS. THE CLINIC PROVIDED BERLIN HEART WITH A VIDEO OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT, BASED ON WHICH THE SOUND COULD BE CONFIRMED. NO IMAGE MATERIAL WAS PROVIDED TO ASSESS THE MEMBRANES. THE AFFECTED BLOOD PUMP WAS RETURNED TO BERLIN HEART FOR ANALYSIS FOLLOWING THE EXCHANGE. THE CUSTOMER COMPLAINT CAN BE CONFIRMED. INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP CONFIRMED UNEVEN BUMPS ON THE MEMBRANES. DURING FUNCTIONAL TESTING OF THE RETURNED PUMP, UNUSUAL PUMPING SOUNDS COULD BE CONFIRMED, SIMILAR TO THE SOUNDS HEARD IN THE CLINIC'S VIDEO. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. ALL THREE MEMBRANE LAYERS LAY PARALLEL TO ONE ANOTHER. NO ABNORMALITIES WERE DETECTED IN THE THREE MEMBRANE LAYERS. PARTICLES WERE NOTED BETWEEN THE MEMBRANE LAYERS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY EXAMINED. GRAPHITE AGGLOMERATES WERE FOUND BETWEEN THE MEMBRANES, WHICH APPEARED AS BUMPS ON THE MEMBRANE, CONFIRMING THE CLINIC'S OBSERVATION. ALL THREE MEMBRANE LAYERS WERE INTACT. AT THE TIME OF RE-MEASUREMENT, THE THICKNESS OF THE AIR-SIDE LAYERS AT ALL THE FIXED LOCATIONS WAS FOUND TO BE WITHIN SPECIFICATION. THE MEASUREMENT ADDITIONALLY SHOWED THAT THE THICKNESS PROFILE OF THE MIDDLE AND BLOOD-SIDE LAYER WAS FOUND NOT TO BE HOMOGENOUS. THE CAUSE OF THE MEMBRANE ABNORMALITY IS MOST LIKELY DUE THE GRAPHITE PARTICLES FORMED BY ABRASION BETWEEN THE MEMBRANES. THE RESULTING GRAPHITE AGGLOMERATES LED TO AN OPTICAL ABNORMALITY. DURING OPERATION OF BLOOD PUMPS, PUMPING SOUNDS CAN BE HEARD. PUMPING SOUNDS CAN VARY FROM PUMP TO PUMP AND GET LOUDER WITH 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.

    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 (33 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 YET BEEN RETURNED TO US. A FOLLOW-UP REPORT WITH THE RESULTS OF A DETAILED INVESTIGATION WILL BE PROVIDED AS SOON AS AVAILABLE. THIS PARTICULAR MODEL IS NOT AVAILABLE IN THE USA. HOWEVER, A SIMILAR DEVICE IS AVAILABLE, THEREFORE, WE ARE REPORTING UNDER THE MDR REGULATIONS.

    Description of Event or Problem · 0

    WE WERE CONTACTED BY THE CLINIC TO REPORT THAT THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION WAS MAKING AN UNUSUAL SOUND. TINY DIMPLES WERE ALSO NOTED ON THE MEMBRANE SURFACE. THE CLINIC STATED THAT THE PUMP FUNCTION WAS NOT AFFECTED. BERLIN HEART (B)(4) CLINICAL AFFAIRS PERSONNEL RECOMMENDED AN EXCHANGE OF THE AFFECTED BLOOD PUMP. THE BLOOD PUMP WAS EXCHANGED BY TRAINED PROFESSIONALS AT THE CLINIC 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
    129866 EXCOR BLOOD PUMP PU VALVES,10 ML IN/OUT Ø6 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P10P-001X02

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO