BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3003118 · Received March 14, 2013

    Report

    Report Number
    1416980-2013-06092
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 24, 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
    PATIENT

    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. THIS COMPLAINT FOR A REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED. THE ROOT CAUSE WAS COULD NOT BE DETERMINED.

    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 DWELL 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE THE POWER ON THE HC, AND A SYSTEM ERROR 2367 OCCURRED. THE TSR EXPLAINED BOTH SYSTEM ERRORS. THE HP STATED THAT THEY DID NOT NOTICE ANYTHING DIFFERENT ABOUT THE SUPPLIES, NOR DID THEY DO ANYTHING DIFFERENT REGARDING THE SETUP, AND WAS NOT SURE WHY A SYSTEM ERROR 2240 OCCURRED. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED. PATIENT EXTENSIONS WERE IN USE AND HAD BEEN ATTACHED PRIOR TO PRIME. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE BAGS WERE PROPERLY CONNECTED AND THERE WERE NO OPEN CLAMPS ON UNUSED LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES, AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE TSR ADVISED THE HP TO EITHER START ALL OVER WITH NEW SUPPLIES OR TO COMPLETE THERAPY USING MANUAL SUPPLIES. THE TSR ALSO ADVISED THE HP TO CONTACT THEIR REGISTERED NURSE TO NOTIFY THEM OF THE ALARM. THE HP UNDERSTOOD AND WOULD USE MANUAL SUPPLIES. THE HC WAS OPERATIONAL. 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
    107056 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE