BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16342459 · Received February 9, 2023

    Report

    Report Number
    3008454189-2023-00004
    Event Type
    Injury
    Date Received
    February 9, 2023
    Date of Event
    January 31, 2023
    Report Date
    February 9, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(4), IS IN USE ON THE PATIENT SINCE (B)(6) 2022 AND AS OF (B)(6) 2023 PATIENT STILL ON THE DEVICE (186 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N 2021795. THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    THE SITE CONTACTED CLINICAL AFFAIRS ON (B)(6) 2023 TO DISCUSS INCREASED GRAPHITE ON THE AIR CHAMBER SIDE OF THE BLOOD PUMP. THE SITE ALSO MENTIONED THERE WERE "SOFT SQUEAKS" IN THE PUMP, BUT NOTHING OF GREAT CONCERN TO THEM. THE SITE ALSO REPORTED THAT PATIENT DOES HAVE INCREASING LDH LEVELS, 1992 AS OF (B)(6) 2023. ACCEPTABLE UPPER RANGE FOR THE SITE IS 575. CLINICAL AFFAIRS SENT A PHOTO OF THE PUMP WITH GRAPHITE SENT BY THE SITE TO BERLIN HEART GMBH FOR REVIEW. BERLIN HEART GMBH RECOMMENDED UPSIZING THE PUMP, HOWEVER, IMMEDIATE CHANGEOUT IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817713 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 2 YR Male Other