BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8168852 · Received December 17, 2018

    Report

    Report Number
    3004582654-2018-00065
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 17, 2018
    Report Date
    December 17, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    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 (82 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 CLINIC PROVIDED BERLIN HEART WITH IMAGES AND A VIDEO OF THE BLOOD PUMP AT THE TIME OF THE INCIDENT. BASED ON THE IMAGES FROM THE CLINIC, A DARK RED DISCOLORATION OF THE MEMBRANE INTERSTICES CAN BE CONFIRMED. THIS SUGGESTS A RUPTURE OF BLOOD SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. A REDUCED PUMPING FUNCTION COULD NOT BE CONFIRMED BASED ON THE PROVIDED PICTURE AND VIDEO. THE IMAGES AND VIDEO FROM THE CLINIC INDICATE A RUPTURE OF THE BLOOD-SIDE LAYER OF THE TRIPLE LAYER MEMBRANE. SINCE THIS PUMP HAS NOT BEEN RETURNED TO THE MANUFACTURER, THE CAUSE FOR THE PUMP CONDITION CANNOT BE DETERMINED. 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 INFORMED BY THE CLINIC THAT BLOOD WAS VISIBLE IN THE MEMBRANE INTERSTICES OF AN EXCOR BLOOD PUMP SUPPORTING A PATIENT IN THE LVAD CONFIGURATION. ADDITIONALLY, THE PUMP FUNCTION APPEARED TO BE REDUCED. THE AFFECTED PUMP WAS EXCHANGED BY TRAINED PERSONNEL AT THE CLINIC. THE EXCHANGE WAS PERFORMED WITHOUT COMPLICATIONS AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011336 EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR