BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2850887 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06117
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS 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. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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 FILL 1 OF 4. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM, AND THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTION. THERE WERE NO PATIENT EXTENSION LINES IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. ONE OF THE BAGS HAD DISCONNECTED FROM THE SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MESSAGE TO THE HOME PATIENT (HP) AND INFORMED HER TO START OVER USING NEW SUPPLIES. THE TSR ADVISED THE HP TO INFORM HER REGISTERED NURSE ABOUT THE EVENT. PROPER PROCEDURES WERE REVIEWED AND THERE WERE NO SAMPLES AVAILABLE. THE LOT NUMBER WAS UNKNOWN. THE HC WAS OKAY. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR HOMECHOICE