BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3073043 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10082
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 31, 2013
    Report Date
    March 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) AND THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION, LOT NUMBER WAS NOT PROVIDED FOR A BATCH REVIEW AND USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) ALARM OCCURRED DURING DRAIN 5 OF 5 ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CLEARED THE ALARM AND INFORMED THE HOME PATIENT (HP) OF THE ERROR'S MEANING. THE HP WOULD DISCONNECT AND DO A MANUAL EXCHANGE TO COMPLETE THERAPY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175080 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE