BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2974810 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04511
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 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). THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. AN EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LEAK, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE; THE PATIENT WAS NOT CONNECTED. THE HOME PATIENT (HP) STATED THAT SHE WAS TAKING THE SUPPLIES OFF OF THE HC WHEN SHE REALIZED THAT THE HEATER BAG WAS NOT CONNECTED PROPERLY TO THE CASSETTE AS THERE WAS FLUID COMING OUT FROM THE CONNECTION. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO DISCUSS THIS EVENT WITH HER REGISTERED NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE EVENT. THE HP SAID THAT SHE DID NOT NOTICE ANYTHING WRONG WITH THE SUPPLIES THAT DAY. SHE SAID SHE WAS NOT SURE WHY THE CONNECTION HAD COME UNDONE. SINCE THEN, SHE HAS BEEN COMPLETING THERAPY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77674 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR HOMECHOICE