BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAKE POST PUMP A/V BLOODLINE SET

    MDR report key: 24870 · Received August 8, 1994

    Report

    Report Number
    2243621-1994-01065
    Event Type
    Injury
    Date Received
    August 8, 1994
    Date of Event
    June 29, 1994
    Report Date
    July 5, 1994
    Manufacturer
    ALTHIN CD MEDICAL, INC.
    Product Code
    FKK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTED, 15 MIN INTO PT'S HEMODIALYSIS TREATMENET THE ARTERIAL BLOOD LINE AT BLOOD PUMP SEGMENT WAS NOTED TO HAVE A "SPLIT" IN IT. THESE LINES WHERE BEING USED WITH A COBE CENTURY 2 SYSTEM. ESTIMATED BLOOD LOSS 200CC TO 250CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAKE POST PUMP A/V BLOODLINE SET HEMODIALYSIS FKK ALTHIN CD MEDICAL, INC. 205-506 PS264E20

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention