BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3241952 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19386
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE, THEREFORE NO EVALUATION COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM ERROR 2240 (AIR IN TUBING) ALARM. THIS OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE POTENTIAL CAUSES. THE TSR HAD THE HOME PATIENT (HP) CLOSE ALL OF THE CLAMPS AND CYCLE THE POWER. THE HP REMOVED THE CASSETTE. THE TSR ADVISED THE HP TO DISPOSE OF THE CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE EVENT WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343312 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR HOMECHOICE