BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2990441 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05324
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A, SYSTEM ERROR 2240 (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) RECEIVED THE ERROR THE PAST NIGHT. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED AND NO PATIENT EXTENSIONS WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE HP HAD SINCE DISCONNECTED AND DISCARDED THE SUPPLIES. THE BAXTER TECHNICAL SERVICES REPRESENTATIVE REVIEWED THE ALARM'S MEANING. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER. SHE STATED THAT THERE WERE NO ISSUES WITH THE SET UP AND NOTHING UNUSUAL WAS NOTED ABOUT THE SUPPLIES. THE PATIENT ENDED THERAPY FOR THE NIGHT AFTER THE ALARM. THERAPY HAS BEEN GOING WELL SINCE, AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92918 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE