BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1973806 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01297
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    November 4, 2010
    Report Date
    January 6, 2011
    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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION. THE SYSTEM ERROR (SE) 2240 WAS IDENTIFIED DURING A REVIEW OF A RETURNED HOMECHOICE (HC) DEVICE WITH OCCURRENCE ON (B)(6) 2010; THERE WAS NO REPORT FOR THIS ALARM CALLED IN BY THE CUSTOMER. A ROOT CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).THERE IS NO EVIDENCE THAT PROBLEMS WITH THE HC CONTRIBUTED TO SE 2240. A ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THE SYSTEM ERROR 2240 WAS FOUND IN THE REVIEW OF THE PATIENT LOGS OF HOMECHOICE (HC).

    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 43 YR HOMECHOICE CYCLER