BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8053041 · Received November 8, 2018

    Report

    Report Number
    3004582654-2018-00055
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 8, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) 2018 (87 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. GRAPHITE PARTICLES WERE OBSERVED IN THE AIR CHAMBER OF THE RETURNED BLOOD PUMP UPON INITIAL INSPECTIONS. INVESTIGATION OF THE AFFECTED PUMP IS CURRENTLY ONGOING AND 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). THE CLINIC PROVIDED BERLIN HEART WITH PICTURES OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. BASED ON THESE PICTURES, BLACK PARTICLES IN THE AIR CHAMBER AND DRIVING TUBE CAN BE CONFIRMED. BERLIN HEART INC. SENT THE AFFECTED BLOOD PUMP TO AN EXTERNAL PATHOLOGY LABORATORY FOR ANALYSIS. THE LABORATORY ANALYSIS REPORT WAS MADE AVAILABLE TO THE MANUFACTURER AND THE INTERPRETATION OF THE RESULTS AS FOLLOWS: MATERIAL FROM THE BLOOD-CHAMBER AND AIR-CHAMBER OF THE AFFECTED PUMP AND FROM THE AORTIC CANNULA PORTION RETURNED WITH THE PUMP WERE SMEARED ONTO THREE SEPARATE SEM STUBS AND SUBMITTED FOR SEM/EDS ANALYSIS. AIR-CONTACTING CHAMBER MATERIAL: EDS ANALYSIS OF THE MATERIAL REVEALED LOCALIZED CONCENTRATIONS OF CARBON AND OXYGEN. CARBON AND OXYGEN ARE ALSO COMPONENTS OF THE POLYMER MATERIAL AND THEIR DETERMINATION WAS TO BE EXPECTED. AORTIC CANNULA MATERIAL: EDS ANALYSIS OF THE MATERIAL REVEALED LOCALIZED CONCENTRATIONS OF CARBON, OXYGEN, NITROGEN, SODIUM, CHLORINE, AND SULFUR. THESE ELEMENTS ARE COMPONENTS OF THE HUMAN BODY (BLOOD, PROTEINS ETC.) AND THEREFORE THEIR DETERMINATION WAS TO BE EXPECTED. BLOOD-CONTACTING CHAMBER MATERIAL: EDS ANALYSIS OF THE FIRST PARTICULATE MATTER OF INTEREST REVEALED LOCALIZED CONCENTRATIONS OF CARBON, OXYGEN, CALCIUM, TITANIUM, AND SILICON. OF NOTE, THE SOURCE OF THE TITANIUM SIGNAL ON EDS OF SOME SAMPLES IS UNKNOWN. A SECOND MATERIAL OF INTEREST REVEALED LOCALIZED CONCENTRATIONS OF CARBON, OXYGEN, SODIUM, CHLORINE, POTASSIUM, SULFUR, AND NITROGEN. THESE ELEMENTS (EXCEPT TITANIUM) ARE COMPONENTS OF THE HUMAN BODY (BLOOD, PROTEINS ETC.) AND THEREFORE THEIR DETERMINATION WAS TO BE EXPECTED. HOWEVER, BASED ON RESULTS OF REPEATED EDS ANALYSIS BY THE MANUFACTURER, IT IS ASSUMED THAT THE ORIGIN OF THE TITANIUM MAYBE DUE TO CONTAMINATION OF THE EXAMINED SAMPLE DURING COLLECTION OF THE TEST SPECIMEN, SINCE THE CONNECTOR OF THE BLOOD PUMP WAS MADE OUT OF TITANIUM. DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, NO ABNORMALITIES WERE TO BE NOTED EXCLUDING THE PARTICLES IN THE AIR CHAMBER. BLACK-BROWN PARTICLES COULD ALSO BE SEEN IN THE RETURNED CANNULA SECTIONS. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE WHERE IT MET ITS REQUIRED PUMPING SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS SUBMITTED FOR AN EXTERNAL CT EXAMINATION. BASED ON THE CT IMAGES, THE MEMBRANE LAYERS WERE FOUND TO BE LYING PARALLEL TO ONE ANOTHER. A FEW SMALL PARTICLES WERE SEEN BETWEEN THE MEMBRANES IN THE CT SCANS. THE MIDDLE LAYER APPEARED TO HAVE SEVERAL LEAKS. THE PUMP WAS THEN DISASSEMBLED FOR FURTHER TESTING AND THE MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. SEVERAL LEAKS WERE CONFIRMED IN THE MIDDLE LAYER LOCATED CLOSE TO THE CENTER AND THE EDGE. THE AIR-SIDE AND BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE WERE FOUND TO BE INTACT. THE THICKNESS OF THE INDIVIDUAL MEMBRANE LAYERS OF THE RETURNED BLOOD PUMP WAS MEASURED AT FIXED POINTS. AT THE TIME OF INVESTIGATION, THE THICKNESS OF THE INDIVIDUAL LAYERS AT ALL THE FIXED LOCATIONS AND ALSO AT THE DEFECT LOCATIONS IN THE MIDDLE LAYER WAS FOUND TO BE WITHIN SPECIFICATION. ONCE THE PUMP IS IN USE ON A PATIENT, GRAPHITE POWDER PARTICLES MAY COME LOOSE FROM THE OUTER SURFACE OF THE AIRSIDE LAYER AND COULD BE VISIBLE IN THE AIR CHAMBER OF THE PUMP. DURING OPERATION, THE AIR CHAMBER IS ALTERNATELY EVACUATED AND FILLED VIA THE DRIVING TUBE. SINCE THERE IS NO FILTER BETWEEN THE AIR CHAMBER OF THE BLOOD PUMP AND THE DRIVING TUBE, THE LOOSE PARTICLES FROM THE AIR CHAMBER CAN BE TRANSPORTED INTO THE DRIVING TUBE DURING THE EVACUATION PHASE. THE ASSESSMENT OF THE AMOUNT OF PARTICLES IS SUBJECTIVE HERE. DETAILED INVESTIGATION OF THE BLOOD PUMP REVEALED THAT THE BLOOD MEMBRANE IS INTACT. BASED ON THIS, THERE CAN BE NO OPEN CONNECTION BETWEEN THE BLOOD CONTACTING SURFACES OF THE CANNULAS AND THE GRAPHITIC SURFACES OF THE BLOOD PUMP. BLOOD REMAINS, WHICH HAVE A BLACK-BROWN APPEARANCE, ARE DEPOSITED REPEATEDLY AT THE JUNCTIONS OF CONNECTORS AND CANNULAS. WHEN SEPARATING THE CANNULA FROM THE CONNECTOR, DUE TO THE ADHESIVE NATURE OF THE SILICONE SURFACE, THE COAGULATED BLACK-BROWN BLOOD REMNANTS MAY ADHERE THERE. A DEFECT WAS DETECTED IN THE MIDDLE LAYER. THE CAUSE OF THIS FAILURE 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 MIDDLE LAYER OF THE TRIPLE-LAYER MEMBRANE. THE PATIENT WAS SUFFICIENTLY SUPPORTED WITH THE AFFECTED BLOOD PUMP FOR 87 DAYS.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC THAT A SIGNIFICANT AMOUNT OF GRAPHITE PARTICLES WAS NOTED IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC REPORTED THAT THE FUNCTION OF THE EXCOR BLOOD PUMP WAS NOT IMPAIRED AND PROVIDED PICTURES OF THE BLOOD PUMP. UPON EVALUATION OF THE IMAGE TOGETHER WITH BERLIN HEART (B)(4), BERLIN HEART INC. RECOMMENDED AN IMMEDIATE EXCHANGE OF THE AFFECTED BLOOD PUMP. TRAINED PERSONNEL AT THE CLINIC PERFORMED THE EXCHANGE THE NEXT MORNING ((B)(6) 2018). FOLLOWING THE EXCHANGE OF THE BLOOD PUMP, THE SURGEON FURTHER REPORTED THE PRESENCE OF GRAPHITE ABRASION IN THE ARTERIAL CANNULA AND THE DRIVING TUBE. THE EXCHANGE OF THE AFFECTED BLOOD PUMP WAS COMPLETED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891156 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 5 MO