BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1984530 · Received February 11, 2011

    Report

    Report Number
    1423500-2011-01771
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    June 20, 2010
    Report Date
    September 30, 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 FOUND DURING A REVIEW OF THE EVENT LOGS OF THE HC DEVICE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE. BAXTER HAS FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM AND WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE. 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 DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 WAS FOUND DURING A REVIEW OF THE EVENT LOGS OF A RETURNED HOMECHOICE (HC) DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE DIALYSIS DEVICE