BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE C3

    MDR report key: 56892 · Received December 13, 1996

    Report

    Report Number
    56892
    Event Type
    Injury
    Date Received
    December 13, 1996
    Date of Event
    November 30, 1996
    Report Date
    December 12, 1996
    Manufacturer
    COBE RENAL CARE, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    VENOUS NEEDLE DISLODGED. DIALYSIS MACHINE DID NOT SOUND ALARM TO INDICATE DISLODGED NEEDLE OR DECREASED VENOUS PRESSURE. 400-600 CC BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE C3 DIALYSIS MACHINE FII COBE RENAL CARE, INC. 333103001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention