BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM

    MDR report key: 7273392 · Received February 15, 2018

    Report

    Report Number
    3004582654-2018-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 20, 2018
    Report Date
    February 15, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. 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. INITIAL VISUAL INVESTIGATION OF THE RETURNED PUMP INDICATES A DEFECTIVE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. A DETAILED INVESTIGATION OF THE RETURNED PUMP IS CURRENTLY ONGOING.

    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, REDDISH-BROWN DEPOSITS COULD BE DETECTED IN THE MEMBRANE INTERSTICES. THIS LEADS TO THE PRESUMPTION OF A DEFECT IN THE BLOOD-SIDE LAYER. NO AIR CUSHIONS WERE DETECTED BETWEEN THE MEMBRANE LAYERS. FUNCTIONAL TESTING OF THE RETURNED PUMP INDICATED THAT IT MET ITS REQUIRED FUNCTIONAL SPECIFICATION. FOR FURTHER INVESTIGATION, THE PUMP WAS DISASSEMBLED AND THE MEMBRANE LAYERS WERE EXAMINED INDIVIDUALLY. HERE, A LEAK WAS DETECTED IN THE BLOOD-SIDE LAYER, CLOSE TO THE PUMP HOUSING. AT THE TIME OF INVESTIGATION, A REDUCED MEMBRANE THICKNESS WAS NOTED AT THE EDGE REGION OF THE MEMBRANE WHERE THE LEAK IS LOCATED. THE REMAINING TWO LAYERS WERE FOUND TO BE INTACT. DURING NORMAL PUMPING FUNCTION, MEMBRANES CAN GET STRESSED, AS A RESULT IF MEMBRANE THICKNESS WAS BELOW THE REQUIRED THICKNESS, THERE IS A POSSIBILITY THAT MEMBRANE LEAKAGE CAN OCCUR AT THE THINNEST POINT OF THE MEMBRANE. A REDUCED MEMBRANE THICKNESS WAS FOUND TO BE THE CAUSE OF THE MEMBRANE RUPTURE. THE PUMP MEMBRANES ARE MADE BY A MANUAL DIPPING PROCESS BY OPERATORS, THEREFORE, A MINIMAL VARIABILITY IN MEMBRANE THICKNESS IS POSSIBLE.

    Description of Event or Problem · 0

    THE SITE CALLED BERLIN HEART INC. ON (B)(6) 2018 TO REPORT THAT BLOOD WAS VISIBLE IN THE MEMBRANE INTERSTICES OF A LEFT EXCOR BLOOD PUMP ON A PATIENT SUPPORTED WITH EXCOR VAD SYSTEM IN AN LVAD CONFIGURATION. THE PUMP CONTINUED TO FILL AND EMPTY COMPLETELY. UPON EVALUATION OF THE VIDEO PROVIDED BY THE CLINIC, BERLIN HEART INC. RECOMMENDED AN IMMEDIATE EXCHANGE OF THE AFFECTED BLOOD PUMP. THE BLOOD PUMP WAS EXCHANGED IN THE CLINIC BY TRAINED PERSONNEL WITHOUT COMPLICATIONS. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THIS INCIDENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117657 EXCOR BLOOD PUMP PU VALVES, 25 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR