BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2771152 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01502
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 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 LOOSE CONNECTION. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. PER THE CUSTOMER THE SAMPLE WAS DISCARDED 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 DWELL 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARMS AND HAD THE CARE GIVER (CG) CYCLE THE POWER TWICE TO CLEAR THEM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING AND NO PATIENT EXTENSION LINES WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE. AFTER GOING THROUGH THE TROUBLESHOOTING QUESTIONS, THE CG REALIZED THAT THE SUPPLY BAG CONNECTION WAS NOT TIGHT AND THAT THE TOWEL UNDER IT WAS A LITTLE WET; IT APPEARED THAT IT HAD NOT BEEN FIRMLY ATTACHED. THE TSR EXPLAINED THAT THE SUPPLIES WERE COMPROMISED. THE HOME PATIENT (HP) WANTED TO END THERAPY FOR THE NIGHT. THE TSR ADVISED THE CG TO CALL THE HP'S REGISTERED NURSE IN THE NEXT 24 HOURS AND LET HER KNOW WHAT HAPPENED, AS WELL AS ALERTING HER TO ANY MISSED THERAPY. THE CG UNDERSTOOD. PROPER PROCEDURES WERE REVIEWED AND THERE WERE NO SAMPLES AVAILABLE. 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 83 YR HOMECHOICE