BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3191615 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16503
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT AVAILABLE FOR ANALYSIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) HAD RECEIVED A SYSTEM ERROR 2240 (AIR IN LINE) ALARM, WITH A CASCADING SYSTEM ERROR 2367 ALARM. THIS OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN, WHILE THE HP WAS CONNECTED. THE SUPPLIES HAD BEEN PROPERLY PRIMED AND THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE PATIENT TO START OVER THERAPY WITH NEW SUPPLIES. THERE WAS NO ADVERSE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291523 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR HOMECHOICE