BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE DIALYSIS MACHINE

    MDR report key: 29365 · Received December 12, 1995

    Report

    Report Number
    29365
    Event Type
    Injury
    Date Received
    December 12, 1995
    Date of Event
    November 30, 1995
    Report Date
    December 11, 1995
    Manufacturer
    CGH MEDICAL, INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DIALYSIS MACHINE REMOVED 10 POUNDS OF FLUID IN TWO HRS RATHER THAN 9 POUNDS IN FOUR HOURS AS WAS PROGRAMMED. NO ALARM INDICATORS LIT AND AUTOTEST WAS NEGATIVE, ALSO WATER LEAKED. BIOMED DISCOVERED THE PRV3 DIAPHRAGM WAS TORN. THE PT FELT "FUNNY," WAS DIZZY AND PALE, SHE REQUIRED NORMAL SALINE SOLUTION INFUSION OF 200 CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE DIALYSIS MACHINE DIALYSIS MACHINE FII CGH MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention