BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    MDR report key: 191543 · Received October 9, 1998

    Report

    Report Number
    1423500-1998-01774
    Event Type
    Malfunction
    Date Received
    October 9, 1998
    Date of Event
    September 20, 1998
    Report Date
    September 20, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A DIALYSIS HOME PT REPORTED A SYSTEM ERROR 2240 ALARM IN DWELL 4/4 DURING TREATMENT USING HOMECHOICE DEVICE. THE PT NOTED A LEAK IN THE SUPPLY LINE OF THE HOMECHOICE SET CAUSE BY HIS PET CAT CHEWING THROUGH THE LINE WHILE THE PT WAS SLEEPING. THE PT WAS INSTRUCTED TO DISCONTINUE TREATMENT AT THE TIME OF THE ALARM. FOUR DAYS FOLLOWING THIS INCIDENT, THE PT WAS HOSPITALIZED FOR 3 DAYS WITH PERITONITIS. THE PT WAS TREATED WITH ANCEF IP, 1 GM X 14DAYS, AND IS RESPONDING TO TREATMENT, ACCORDING TO THE HEALTH CARE PROFESSIONAL. FOLLOW UP WITH THE HEALTH CARE PROFESSIONAL REVEALED SHE WAS UNAWARE THE PT HAD PETS. THE HEALTH CARE PROFESSIONAL WILL F/U WITH THE PT REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O