BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3083661 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10743
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    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. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM ERROR 2240 (AIR IN TUBING) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. HOWEVER DURING TROUBLESHOOTING, NOTHING WAS FOUND THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) CYCLE THE POWER AND THE HC ALARMED WITH A SYSTEM ERROR 2367. THE TSR THEN HAD THE CG CYCLE THE POWER, IN ORDER TO END THERAPY, AND HAD THE CG DISCONNECT THE HOME PATIENT (HP). THE TSR ADVISED THE CG TO CONTACT THEIR REGISTERED NURSE (RN). 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
    183654 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE