BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 246664 · Received October 25, 1999

    Report

    Report Number
    1423500-1999-01291
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    September 24, 1999
    Report Date
    September 24, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CARETAKER OF HOME PT (HP) REPORTS SWITCHING USED SOLUTION BAG TO ALREADY SPIKED HEATER LINE OF HOMECHOICE SET, WHILE TROUBLESHOOTING AN ALARM SITUATION DURING APD TREATMENT. CARETAKER WAS ADVISED BY BAXTER TECHNICIAN TO ASSIST HP IN ENDING TREATMENT AT THAT TIME, AND TO RESTART WITH NEW SUPPLIES. CARETAKER REPORTS NO PT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF INCIDENT.

    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 UNKNOWN