BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3945757 · Received July 21, 2014

    Report

    Report Number
    1416980-2014-23407
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, THE PATIENT REPORTED THAT THEY WERE UNSURE IF THE PATIENT LINE WAS FULLY PRIMED 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. IT PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. ALSO, IT WARNS THE USER THAT CONNECTING THE TRANSFER SET TO THE PATIENT LINE BEFORE CONNECT YOURSELF APPEARS ON THE DISPLAY SCREEN MAY RESULT IN IIPV OR CAN CAUSE AIR TO BE DELIVERED TO THE PERITONEAL CAVITY. 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 THERE WAS AIR IN THE PATIENT LINE OF A HOMECHOICE AUTOMATED PD SET WITH CASSETTE DURING INITIAL DRAIN ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, THE PATIENT INDICATED THAT THEY WERE UNSURE IF THE PATIENT LINE HAD BEEN FULLY PRIMED BEFORE CONNECTING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT IN ENDING THERAPY AND ADVISED THE PATIENT TO RESTART 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
    426636 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HOMECHOICE