BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2222608 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11217
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SET WAS VISUALLY INSPECTED WITH SOLUTION NOTED IN SET. THE SET WAS PLACED ON MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. THE SET WAS TESTED UNDERWATER AT 8 PSI WITH NO LEAK NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION OF THE HOME CHOICE SET. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. THE CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240, WHICH OCCURRED ON THE HOME CHOICE (HC) SYSTEM DURING DRAIN 1 OF 7. THE HP WAS ADVISED TO DISPOSE OF THE CURRENT SUPPLIES. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. BAXTER CONTACTED THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THE FOLLOWING: NOTHING WAS SEEN THAT WOULD HAVE CAUSED THE ALARM AND NEW SUPPLIES WERE USED TO CLEAR THE ALARM. THE SAMPLE WAS DISCARDED AND A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED. THE PATIENT WAS DOING FINE WITH THERAPY SINCE THE EVENT AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HOME CHOICE