BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120371 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07439
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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 CONNECTION ISSUE WAS NOT CONFIRMED. THE ROOT CAUSE WAS A "BAG HAD DISCONNECTED." 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. SAMPLE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) ABOUT A CONNECTION ISSUE THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING USE. THE HP STATED THAT THE BAG HAD BECOME DISCONNECTED, AND THE BAG FILLED WITH AIR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE HP IF THEY STILL HAD THE SUPPLIES BUT THE HP SAID NO. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OF 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 61 YR HOME CHOICE