BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3181351 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16093
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE" WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY. THE GUIDE INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) NOTICED AN OPEN CLAMP ON AN UNUSED SUPPLY LINE WHEN CALLING FOR ASSISTANCE WITH OTHER ALARMS WHILE CONNECTED TO THE HOMECHOICE DURING DRAIN ONE OF FIVE. THE HP HAD TRIED TO OPEN THE DOOR. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE HP AND ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282049 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE