BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FKX

    MDR report key: 5833726 · Received July 29, 2016

    Report

    Report Number
    1416980-2016-12356
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    July 7, 2016
    Report Date
    July 29, 2016
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A USER ERROR WHERE THE PATIENT DID NOT TIGHTEN THE CONNECTION BETWEEN THE HEATER BAG AND CASSETTE LINE, WHICH CAUSED A DISCONNECTION BETWEEN THE HEATER BAG AND CASSETTE LINE. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO 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. ALSO, IT INSTRUCTS THE USER TO CHECK LINES FOR DISCONNECTED SOLUTION BAGS. IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR CONNECTING THE SOLUTION BAGS. IT WARNS THE USER THAT IF A BAG BECOMES DISCONNECTED DURING THERAPY, THE USER SHOULD FOLLOW THE END THERAPY EARLY PROCEDURE. 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 THE HEATER BAG DISCONNECTED FROM THE HEATER LINE OF A HOMECHOICE CASSETTE DURING PRIMING OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, THE PATIENT STATED THAT THEY HAD NOT TIGHTENED THE CONNECTION BETWEEN THE HEATER BAG AND THE HEATER LINE OF THE CASSETTE. THE PATIENT WOULD START THERAPY OVER WITH NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485085 FKX FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR HOMECHOICE