BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2961541 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03761
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF A LEAK WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LEAK WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THAT THE CASSETTE HAD STARTED TO LEAK, SO SHE HAD TAKEN DOWN THE SETUP AND DISPOSED OF IT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO SETUP WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT. SHE STATED THAT FLUID WAS LEAKING OUT OF THE HOMECHOICE DOOR. SHE DID NOT KNOW WHERE THE LEAK IN THE CASSETTE WAS COMING FROM, AND SHE DID NOT NOTICE ANYTHING UNUSUAL ABOUT HER SUPPLIES. THE PATIENT'S THERAPY HAS BEEN GOING WELL SINCE, AND THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65059 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