BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3231621 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18755
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT "GO" WAS PRESSED PRIOR TO PATIENT CONNECTION, WHICH IS A USER ERROR. 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 PRIMING THE DISPOSABLE SET AND FOR WHEN AND HOW TO CONNECT TO THE DISPOSABLE SET. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM HAD OCCURRED ON THE HOMECHOICE (HC) DEVICE. THIS OCCURRED DURING THE INITIAL DRAIN. THE CARE GIVER (CG) STATED THAT "GO" WAS PRESSED PRIOR TO THE HOME PATIENT (HP) BEING CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CLOSE ALL THE CLAMPS AND CYCLE THE POWER IN ORDER TO CLEAR THE ALARM. THE TSR ADVISED THE CG TO START OVER WITH NEW SUPPLIES. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330480 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE