BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2873349 · Received December 14, 2012

    Report

    Report Number
    1416980-2012-07346
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    December 9, 2012
    Report Date
    December 9, 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 SYSTEM ERROR 2240 (AIR IN SET) IS CONFIRMED; PER THE COMPLAINT INFORMATION THE LIKELY CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS A LOOSE CONNECTION BETWEEN LINE AND SUPPLY BAG, WHICH IS A USE ERROR THAT CAN CAUSE SYSTEM ERROR 2240 ALARMS. THE CARE GIVER STATED THE HEATER BAG WAS NOT CONNECTED PROPERLY. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    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 BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN LINE) DURING THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE CAREGIVER (CG) CYCLED THE POWER ON THE HC AND THE HC ALARMED SYSTEM ERROR 2367. THE CG CYCLED THE POWER ON THE HC AND PROCEEDED TO PRESS GO TO START. THE CG STATED THE HEATER BAG WAS NOT CONNECTED PROPERLY. THE TSR ADVISED THE CG TO START OVER WITH ALL NEW SUPPLIES AND INFORM THE REGISTERED NURSE (RN) OF THE SE 2240. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 78 YR HOMECHOICE