BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1943222 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07461
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 7, 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). A SYSTEM ERROR (SE) 2240 WAS IDENTIFIED DURING A REVIEW OF A RETURNED HOMECHOICE (HC) DEVICE LOGS WITH OCCURRENCE DATE (B)(6) 2010 IN DRAIN 1/5; THERE WAS NO REPORT FOR THIS ALARM CALLED IN BY THE CUSTOMER. THERE IS NO EVIDENCE THAT PROBLEMS WITH THE HC CONTRIBUTED TO SE 2240. THE CAUSE OF THE COMPLAINT 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 WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 WAS FOUND IN DRAIN 1 OF 5 DURING A REVIEW OF THE PATIENT ALARM LOGS OF THE HOMECHOICE (HC) DEVICE.

    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 65 YR HC CYCLER