BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3130563 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13416
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A BATCH REVIEW COULD NOT BE PERFORMED. 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 MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TROUBLESHOOTING ON THE HOMECHOICE (HC) MACHINE FOR AN UNRELATED ALARM, THE HP HAD REUSED THE SINGLE-USE SUPPLIES. THE HP EXPLAINED THAT THEY TURNED THE MACHINE OFF EARLIER IN THE DAY AFTER THEY DID THEIR DAY FILL AND THEN MOVED THE MACHINE. WHEN THE MACHINE WAS TURNED BACK ON, IT WENT THROUGH THE SETUP AGAIN. THE HP STATED THAT THEY WERE NOT CONNECTED DURING THE SETUP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INQUIRED ABOUT THE PATIENT LINE AND THE HP STATED THAT THE WHITE CLAMP WAS CLOSED ON THE PATIENT LINE WITH THE FLEXI DISCONNECT CAP ON THE LINE. THE TSR EXPLAINED THE ALARM AND INSTRUCTED THE HP TO CONNECT TO THE MACHINE AND START THE INITIAL DRAIN. THE TSR STATED THAT THE HC WOULD BE BACK TO WHERE THE HP NEEDED, ONCE THE HC DID THE DAY FILL AND DWELL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232390 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE