BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3120572 · Received May 20, 2013

    Report

    Report Number
    1416980-2013-12923
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR SYSTEM ERROR 2367 IS NOT CONFIRMED BECAUSE THE CAUSE CODE IS UNDETERMINED, THE SAMPLE WAS NOT RETURNED FOR EVALUATION, AND A BATCH REVIEW WAS NOT PERFORMED TO CONFIRM THE PROBLEM. THE CAUSE COULD NOT BE IDENTIFIED BECAUSE THERE IS NOT ENOUGH INFORMATION IN THE EVENT DESCRIPTION TO DETERMINE AN ASSIGNABLE CAUSES CODE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2367 (AIR IN SET) ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4. THE REGISTERED NURSE (RN) STATES THAT THE HC WAS TRYING TO REFILL THE HEATER; HOWEVER, ALL OF THE BAGS ARE EMPTY. AFTER CYCLING THE POWER, THE HC ALARMED SYSTEM ERROR 2367. THE RN IS REQUESTING ASSISTANCE TO END THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE RN CYCLE POWER TO THE HC AGAIN TO END THERAPY. THERAPY ENDED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221361 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