BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2962693 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03879
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONDITION WAS NOT CONFIRMED, AS THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT REQUESTED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONNECTION ISSUE OCCURRED WHERE THE HEATER LINE BECAME DISCONNECTED FROM THE HEATER BAG ON THE HOME CHOICE (HC) DURING USE. THERE WERE NO ALARMS RECEIVED. THE TSR ADVISED THE HP THAT ANYTIME A LINE DISCONNECTS SHE COULD NOT RECONNECT THE LINE AND CONTINUE THERAPY. THE HP WOULD DO A MANUAL EXCHANGE AND CONTACT THE PDRN. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64997 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE