BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3864071 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18575
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. HOWEVER, IT WAS REPORTED THAT THE PATIENT MADE A MISTAKE AND CONNECTED TO THE DEVICE AT THE TIME OF PRIMING. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND SAYS TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. 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. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNRELATED ALARM ON THE HOMECHOICE (HC) DEVICE, THE HOME PATIENT (HP) HAD MADE A MISTAKE AND CONNECTED DURING THE PRIME. THE HP STATED THAT THEY THOUGHT THAT THE ALARM DISPLAY ON THE HC DEVICE, WAS ACTUALLY A SIGNAL TO CONNECT AND WHEN THEY PRESSED GO, THE HC DISPLAYED THAT IT WAS ¿PRIMING¿. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE PRIME WAS NOT FINISHED AND THAT THEY WOULD NEED TO DISCONNECT AND START OVER WITH NEW SUPPLIES. THE TSR ASSISTED WITH REMOVING THE SET AND THE HP WAS GOING TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338326 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE