BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 3232355 · Received July 18, 2013

    Report

    Report Number
    1416980-2013-18783
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN TUBING) ON THE HOMECHOICE (HC) DURING THE INITIAL DRAIN, WHILE THE HP WAS CONNECTED. THE CG HAD TO START THE THERAPY OVER USING ALL NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333727 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO HOMECHOICE