BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3830981 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16884
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THIS COMPLAINT IS FOR A REPORT OF A USE ERROR DURING A SYSTEM ERROR 2240, WHERE THE HOME PATIENT STARTED THE INITIAL DRAIN 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. THE GUIDE PROVIDES INSTRUCTIONS FOR PROPERLY CONNECTING TO THE HOMECHOICE WHEN STARTING THERAPY. A FORMAL 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING SYSTEM ERROR 2240 THAT OCCURRED ON THE HOMECHOICE (HC) DURING PATIENT USE. THE CAREGIVER (CG) STATED THAT THE PATIENT WAS NOT CONNECTED TO THE PATIENT LINE DURING THE INITIAL DRAIN. THE CG NOTICED THE SE 2240 AND THE HP CONNECTED. THE TSR HAD THE CG CLOSE THE CLAMPS, DISCONNECT THE HP AND CYCLE THE POWER. THE TSR HAD THE CG CYCLE THE POWER AND THE HC WENT TO PRESS GO. THE TSR ASSISTED WITH GETTING THE SET OUT, AND EXPLAINED THE CG CAN START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307527 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE