BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2012379 · Received March 9, 2011

    Report

    Report Number
    1423500-2011-02951
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2267 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR THIS PRODUCT LINE AND TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2267 WHILE USING THE HOMECHOICE (HC) DURING THE LAST FILL. THE PATIENT STATED THE SUPPLY BAG WAS EMPTY AND THE HEATER BAG HAD SOME SOLUTION LEFT. (B)(4) EXPLAINED THE ERROR INDICATED AIR HAD ENTERED INTO THE DISPOSABLE SET, AND HELPED THE PATIENT CLEAR THE ERROR BY CYCLING POWER TWICE. THE PATIENT ELECTED TO COMPLETE THERAPY MANUALLY. NO INJURY OR MEDICAL INTERVENTION WAS 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 47 YR HOMECHOICE