BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3011581 · Received March 19, 2013

    Report

    Report Number
    1416980-2013-06625
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE SYSTEM ERROR 2240 ALARM WAS FOUND TO HAVE AN UNDETERMINED CAUSE. THE PROBLEM CANNOT BE CONFIRMED DUE TO NO USE ERROR DESCRIBED BY THE PATIENT, THE SAMPLE AND LOT NUMBER WERE UNAVAILABLE FOR EVALUATION AND AN EVENT LOG WAS NOT REVIEWED BY A BAXTER EMPLOYEE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING) DURING DWELL 4 OF 4 ON THE HOME CHOICE (HC). THERE WAS NO HOME PATIENT (HP) OR BAG DISCONNECTION. THERE WAS SOLUTION IN THE HEATER BAG. THERE WERE NO LEAKS OR LOOSE CONNECTIONS. THE HP CYCLED THE POWER AND A SYSTEM ERROR 2367 OCCURRED. THE ALARMS WERE CLEARED. THE HP WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113599 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE