BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3873604 · Received June 15, 2014

    Report

    Report Number
    1416980-2014-19080
    Event Type
    Malfunction
    Date Received
    June 15, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 ALARM (AIR IN SET/LINE) OCCURRED ON THE HOMECHOICE (HC) DEVICE DURING DWELL 5 OF 6. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THE HP STATED THAT THE SUPPLY BAGS WERE EMPTY AND THE SOLUTION WAS IN THE HEATER BAG ONLY. THE HP INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THERE WERE NO BAGS WHICH CAME UNDONE. THERE WAS NOTHING UNUSUAL FOUND DURING THE TROUBLESHOOTING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ALARM. THE TSR INSTRUCTED THE HP TO CYCLE THE POWER ON THE HC TO CLEAR THE ALARM. THE TSR ADVISED THE HP TO START OVER USING MANUAL BAGS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351921 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE