BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISYSTEMS ARTERIAL-VENOUS BLOOD TUBING

    MDR report key: 55814 · Received December 9, 1996

    Report

    Report Number
    9680437-1996-00005
    Event Type
    Injury
    Date Received
    December 9, 1996
    Date of Event
    November 18, 1996
    Report Date
    December 6, 1996
    Manufacturer
    MEDISYSTEMS CORPORATION
    Product Code
    FJK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTS THAT AT THE BEGINNING OF PT'S TREATMENT, BLOOD WAS NOTICED LEAKING FROM THE PUMP SEGMENT. EXTIMATED BLOOD LOSS 140-200 CCS. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS ARTERIAL-VENOUS BLOOD TUBING ARTERIAL-VENOUS BLOOD TUBING FOR HEMODIALYSIS FJK MEDISYSTEMS CORPORATION NA 6816K4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other