BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1954820 · Received January 10, 2011

    Report

    Report Number
    1423500-2011-00366
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 30, 2010
    Report Date
    December 16, 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). 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. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO SAMPLE EVALUATION FOR THE SYSTEM ERROR 2240 THAT WAS FOUND IN THE LOGS. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE CAUSE OF THE REPORT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A SYSTEM ERROR (SE) 2240 ALARM WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE DEVICE. THE SYSTEM ERROR OCCURRED ON (B)(6) 2010. A SE 2240 (AIR IN SET) IS A NON-RECOVERABLE ALARM THAT OCCURS WHEN THE DEVICE HAS DETECTED AIR BEING DRAWN CONTINUOUSLY INTO THE DISPOSABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER 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 37 YR HOMECHOICE CYCLER