BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3231572 · Received July 17, 2013

    Report

    Report Number
    1416980-2013-18754
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE CAUSE OF THE ALARM WAS DETERMINED TO BE USE ERROR. 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 INSTRUCTS THE USER TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR (SE) 2240 (AIR IN LINE). THIS OCCURRED DURING THE THIRD FILL CYCLE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT STATED THAT SHE HAD LOOSELY CONNECTED THE HEATER BAG TO THE HEATER LINE. THE CONNECTION HAD SEPARATED AND THE ALARM OCCURRED. THE PATIENT COMPLETED THERAPY USING MANUAL SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331000 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