BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3182880 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16172
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE HOME PATIENT HAD DISCONNECTED FROM THE SUPPLY LINE AND CONNECTED TO THE PATIENT LINE, WHICH IS A USE ERROR THAT CAN CAUSE AIR TO ENTER THE PERITONEAL CAVITY AND/OR CAUSE CONTAMINATION. 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. THIS GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR SETTING UP THE HOMECHOICE FOR THERAPY AND GIVES A VISUALIZATION OF THE SUPPLY LINES AND PATIENT LINE. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY CONNECTING THE PATIENT LINE TO THE TRANSFER SET. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A CALL FOR THERAPY ASSISTANCE, IT WAS FOUND THAT THE HOME PATIENT (HP) HAD CONNECTED HIMSELF TO THE SUPPLY LINE, STARTED THERAPY, AND THEN DISCONNECTED FROM THE SUPPLY LINE AND CONNECTED TO THE PATIENT LINE. THE HP WAS IN INITIAL DRAIN AT THE TIME OF THE CALL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) TO END THERAPY EARLY AND ADVISED THE CG TO NOTIFY THEIR NURSE AND START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283963 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE