BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3854403 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18263
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - FAILED TO FOLLOW THERAPY STEPS, WHERE THE HOME PATIENT CONNECTED TO UN-PRIMED PATIENT LINE. 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 PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. IT INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED AND TO FOLLOW INSTRUCTIONS FOR RE-PRIMING IF THE FLUID LEVEL IS NOT NEAR THE CONNECTOR. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF AN UNRELATED ALARM, IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD CONNECTED TO AN UN-PRIMED PATIENT LINE. THE EVENT OCCURRED DURING USE ON THE HOME CHOICE (HC). THE HP INDICATED THEY WOULD START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332030 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE