BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE C3 WITH BETTER WATER REVERSE OSMOSIS R/O

    MDR report key: 17283 · Received August 30, 1994

    Report

    Report Number
    17283
    Event Type
    Injury
    Date Received
    August 30, 1994
    Date of Event
    August 17, 1994
    Report Date
    August 25, 1994
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH DRAMATIC DECREASE IN HGB SECONDARY TO HEMOLYSIS SUSPECTED DUE TO FAILURE OF THE CARBON FILTER IN THE WATER TREATMENT SYSTEM TO REMOVE CHLORINE/CHLORAMINE FROM DIALYSATE. PT RECEIVED 2 UNITS PRBC'S AND WAS TREATED FOR CHLORINE/CHLORAMINE EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE C3 WITH BETTER WATER REVERSE OSMOSIS R/O HEMODIALYSIS WATER TREATMENT SYSTEM FII CGH MEDICAL, INC. OCEDC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention