BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3162333 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14963
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE. NO EVALUATION OR BATCH REVIEW COULD 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 HAS INSTRUCTIONS ON THE STEPS TO PROPERLY DISCONNECT FROM CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT TO THERAPY AFTER PROPERLY DISCONNECTING. THERE ARE DIRECTIONS TO MAINTAIN ASEPTIC TECHNIQUE WHEN FOLLOWING TROUBLESHOOTING. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) THAT OCCURRED ON THE HOMECHOICE (HC) MACHINE IN DWELL 5 OF 5, PATIENT WAS CONNECTED. IT WAS FOUND THAT THE HP IMPROPERLY DISCONNECT FROM THE SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER OFF AND ON TO CLEAR THE ALARM. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262427 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE