BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 435803 · Received December 24, 2002

    Report

    Report Number
    1423500-2002-01657
    Event Type
    Malfunction
    Date Received
    December 24, 2002
    Date of Event
    December 13, 2002
    Report Date
    December 13, 2002
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT (HP) REPORTS CONTACTING BAXTER'S TECHNICAL SERVICE CENTER FOR ASSISTANCE WHILE TROUBLESHOOTING THROUGH AN ALARM SITUATION DURING HOMECHOICE TREATMENT. IN AN ATTEMPT TO CLEAR THE ALARM, HOME PATIENT REPORTS THEY DISCONNECTED A SUPPLY BAG FROM THE SUPPLY LINE OF THE HOMECHOICE SET, AND THE HEATER BAG FROM THE HEATER LINE OF HOMECHOICE SET, AND SUBSEQUENTLY RECONNECTED THE SUPPLY BAG TO THE HEATER LINE AND THE HEATER BAG TO THE SUPPLY LINE. BAXTER TECHNICIAN ASSISTED HOME PATIENT IN ENDING THERAPY EARLY. NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED PER RN.

    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 CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT| (REFURBISHED).