BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3162537 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14985
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 27, 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). THIS IS A REPORT OF REUSE OF A SINGLE-USE DEVICE. PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE AND ALL THE PRINTED POUCHES FOR DISPOSABLE PRODUCTS THAT ARE 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 REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) REUSED A SINGLE USE PRODUCT (CASSETTE) DURING PERITONEAL DIALYSIS (PD) THERAPY. THE HP CONTACTED BAXTER TECHNICAL SERVICE TO REQUEST ASSISTANCE WITH AN ALARM OCCURRING ON THE HOMECHOICE (HC) DEVICE DURING PD THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) PROVIDED ASSISTANCE AND INSTRUCTED THE HP TO START OVER WITH NEW SUPPLIES. AT THIS POINT, THE HP SAID THEY WANTED TO TRY TO "WIGGLE" SOMETHING (DETAILS NOT PROVIDED). WHEN THE HP CAME BACK ON THE CALL, THE HP SAID THEY ATTACHED 2 DIFFERENT BAGS. THE TSR EXPLAINED THAT THE SUPPLIES WERE NOW COMPROMISED. THE HP WILL HAVE TO END THERAPY ON THE HC FIRST, START OVER WITH ALL NEW BAGS AND A NEW CASSETTE, INCLUDING THE BAGS THEY JUST ATTACHED. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION ASSOCIATED WITH THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262509 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE