BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1891892 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05356
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMERS REPORTED CONDITION OF A SYSTEM ERROR (SE) 2240 ALARM DURING USE WAS NOT CONFIRMED AS A SAMPLE OR BATCH DETAILS WERE NOT AVAILABLE. NO ROOT CAUSE WAS DETERMINED, BUT IS BEING INVESTIGATED THROUGH CAPA # (B)(4). NO USE ERROR WAS SUSPECTED THEREFORE NO LABEL REVIEW WAS REQUIRED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SYSTEM ERROR 2240 WAS FOUND IN THE REVIEW OF THE EVENT LOGS OF HOMECHOICE (HC). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR