BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4233834 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39209
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 DURING THE INITIAL DRAIN, WHERE THE HOME PATIENT STARTED THE INITIAL DRAIN BEFORE CONNECTING. 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 INSTRUCTIONS FOR PROPERLY CONNECTING TO THE HOMECHOICE WHEN STARTING THERAPY. A 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

    IT WAS REPORTED THAT A HOME PATIENT FAILED TO FOLLOW THERAPY STEPS DURING PERITONEAL DIALYSIS THERAPY. THE PATIENT HAD STARTED THE INITIAL DRAIN BEFORE CONNECTING TO THE PATIENT LINE. THE PATIENT THEN CONNECTED TO THE SETUP AFTER THERAPY WAS INITIATED. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HP TO START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715907 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE