BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3131817 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13600
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS A SAMPLE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. 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) ALARM ON THE HOMECHOICE (HC). THE ALARM OCCURRED DURING DRAIN 3 OF 4, WHILE THE HP WAS CONNECTED. THE HP CYCLED THE POWER IN ORDER TO CLEAR THE ALARM AND THE SYSTEM ERROR 2367 ALARM, WHICH FOLLOWED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP DISCONNECT AND REMOVE THE CASSETTE. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO REPORT OF 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
    236870 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR HOMECHOICE