BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES 30ML IN/OUT Ø9MM

    MDR report key: 5505773 · Received March 16, 2016

    Report

    Report Number
    3004582654-2016-00010
    Event Type
    Malfunction
    Date Received
    March 16, 2016
    Date of Event
    February 17, 2016
    Report Date
    February 17, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    H100004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EXCHANGED DURING IMPLANTATION. 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. DURING INITIAL INVESTIGATION OF THE RETURNED BLOOD PUMP NO DEFECT OR ANY ANOMALY WAS DETECTED. HOWEVER, EVALUATION OF THE BLOOD PUMP S/N (B)(4) IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC.(IMPORTER: (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE BLOOD PUMP THAT IS THE SUBJECT OF THIS REPORT (S/N (B)(4)) WAS RETURNED AND EVALUATED BY THE MANUFACTURER OF THE PUMP. THE RETURNED PUMP HAD A CLEAN BLOOD CHAMBER AND CLEAN MEMBRANE INTERSTICES WHICH SUGGEST THAT THE BLOOD PUMP HAD BEEN CLEANED PRIOR TO BEING RETURNED TO (B)(4). ON VISUAL INSPECTION, DRIED REDDISH BROWN RESIDUE WAS FOUND IN THE AIR CHAMBER. 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. FOR BLOOD TO PENETRATE THE BLOOD CHAMBER TO AIR CHAMBER, ALL THREE LAYERS MUST LEAK AND BLOOD HAS TO PASS THROUGH THE MEMBRANE INTERSTICES. HOWEVER, NO BLOOD RESIDUE WAS DETECTED IN THE MEMBRANE INTERSTICES. FOR FURTHER ANALYSIS, THE BLOOD CHAMBER OF THE PUMP WAS PRESSURIZED AND OBSERVED FOR PRESSURE DROP. NO PRESSURE DROP WAS OBSERVED, INDICATING NO LEAK. THEN THE PUMP WAS TESTED FOR ITS PERFORMANCE AND CONFIRMED THAT BLOOD PUMP MET THE OUT PUT SPECIFICATION. ADDITIONALLY, PUMP WAS DISASSEMBLED AND EACH MEMBRANE LAYER WAS EXAMINED FOR DEFECT OR FLUID RESIDUE BETWEEN THE MEMBRANE LAYERS. NO EVIDENCE OF FLUID BEING PASSED THROUGH THE MEMBRANE OR ANY KIND OF DAMAGE WAS NOTED. THEREFORE BASED ON ANALYSIS RESULTS, PUMP IS NOT DEFECTIVE AND FLUID MAY HAVE ENTERED INTO THE AIR CHAMBER INADVERTENTLY THROUGH THE DRIVELINE PORT.

    Description of Event or Problem · 0

    SITE CALLED THE BERLIN HEART INC. CLINICAL HOTLINE ON (B)(6) 2016 TO REPORT THAT DURING THE IMPLANTATION OF EXCOR BLOOD PUMP, THEY HAVE NOTICED BLOOD IN THE AIR CHAMBER OF THE EXCOR BLOOD PUMP AFTER THE PUMP HAD BEEN CONNECTED TO THE PATIENT AND WAS PUMPING. BERLIN HEART INC. CLINICAL AFFAIRS ADVISED THE SITE TO CHANGE THE EXCOR BLOOD PUMP IMMEDIATELY. THE EXCOR BLOOD PUMP WAS EXCHANGED IN THE OPERATING ROOM BY THE IMPLANTING SURGEON. THE EXCHANGE OF EXCOR BLOOD PUMP WAS UNEVENTFUL. THE SITE REPORTED THAT THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161316 EXCOR BLOOD PUMP PU VALVES 30ML IN/OUT Ø9MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001X01 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR