BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2833261 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05209
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 4, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO BATCH REVIEW COULD BE PERFORMED. THE PROBLEM WAS CONFIRMED, BASED ON THE CUSTOMER REPORT. THE ROOT CAUSE WAS USE ERROR - OPEN CLAMP. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE PREVENTION OF THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 2 OF 3. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER AND THE HC THEN ALARMED SE 2367. THE TSR HAD THE HP CYCLE POWER AGAIN AND THE ALARMS CLEARED. THE HP HAD TO COMPLETE THERAPY WITH MANUAL SUPPLIES. THE PATIENT WAS CONNECTED. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE NOT USED. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM. ALL BAGS WERE PROPERLY CONNECTED. THERE WERE OPEN CLAMPS ON THE UNUSED SUPPLY LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. 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