BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4171436 · Received October 14, 2014

    Report

    Report Number
    1416980-2014-35875
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, THIS IS A REPORT WHERE THE HOME PATIENT CONNECTED DURING CONNECT BAGS. 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 THAT CONNECTING THE TRANSFER SET TO THE PATIENT LINE BEFORE "CONNECT YOURSELF" APPEARS ON THE SCREEN MAY RESULT IN IIPV. IT ALSO WARNS THE USER THAT CONNECTING YOURSELF BEFORE "CONNECT YOURSELF" CAN CAUSE AIR TO BE DELIVERED TO THE PERITONEAL CAVITY. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY CONNECTING THE SOLUTION BAGS, AS WELL AS PROVIDES STEP-BY-STEP INSTRUCTIONS FOR CONNECTING THE TRANSFER SET TO THE PATIENT LINE. 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 PATIENT DID NOT FOLLOW PROPER STEPS IN PERITONEAL DIALYSIS THERAPY. THIS OCCURRED DURING SET UP. THE PATIENT CONNECTED TO THE SET UP PRIOR TO PRIMING THE LINE FOR THERAPY. THE PATIENT WAS TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650541 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HOMECHOICE