BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3173627 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15616
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THEREFORE, NO EVALUATION COULD BE PERFORMED. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES AND FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) RECEIVED A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE), WHICH OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING USE. THE HP DISCONNECTED DURING DRAIN TO USE THE BATHROOM AND WHEN THEY RETURNED, THE DEVICE WAS ALARMING. THE PATIENT DID NOT USE PROPER DISCONNECT PROCEDURES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE PATIENT TO CYCLE THE POWER ON THE HC IN ORDER TO CLEAR THE ALARM. THE PATIENT WAS ADVISED TO USE NEW DISPOSABLES OR TO PERFORM MANUAL THERAPY. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273270 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE