BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3222797 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18122
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. PER BAXTER LABELING, ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY". A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TROUBLESHOOTING FOR AN UNRELATED ALARM, THE HOME PATIENT (HP) HAD REUSED SINGLE-USE SUPPLIES ON THE HOMECHOICE (HC) DEVICE DURING FILL 1 OF 4, PATIENT WAS CONNECTED. THE HP STATED THAT THEY HAD CHANGED OUT THE HEATER BAG IN AN ATTEMPT TO CLEAR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF THEY HAD CHANGED ANY OTHER SUPPLIES OR JUST CONNECTED A NEW HEATER BAG TO THE SET UP AND THE HP INDICATED THAT THEY HAD ONLY REPLACED THE HEATER BAG. THE TSR EXPLAINED THAT THE HP HAD COMPROMISED THE SET UP AND WERE RISKING AN INFECTION. THE TSR ASSISTED THE HP WITH ENDING THERAPY AND REMOVING THE CASSETTE. THE TSR EXPLAINED THE PROPER PROCEDURE TO THE HP AND ADVISED TO START OVER WITH ALL NEW SUPPLIES. THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322654 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOMECHOICE