BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3994366 · Received August 8, 2014

    Report

    Report Number
    1416980-2014-25733
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR DURING THE PRIMING STAGE, WHERE THE HOME PATIENT STATED THAT THEY HAD NOT FULLY TIGHTENED THE CONNECTION BETWEEN THE PATIENT LINE EXTENSION AND THE CASSETTE, WHICH RESULTED IN A LEAK. 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 INSTRUCTS THE USER TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK OCCURRED AT THE CONNECTION BETWEEN A PATIENT LINE EXTENSION AND A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THIS OCCURRED DURING THE PRIMING STAGE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. THE PATIENT STATED THAT THEY HAD NOT SECURED THE PATIENT LINE EXTENSION SECURELY TO THE CASSETTE. THE PATIENT PLANNED TO COMPLETE THERAPY USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472632 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE, PATIENT LINE EXTENSION