BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3854085 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18203
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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 WARNS THE USER TO MAKE SURE ALL CLAMPS ON UNUSED FLUID LINES ARE CLOSED SECURELY. THE GUIDE INSTRUCTS THE USER TO CLOSE ALL CLAMPS WHILE PREPARING TO LOAD THE DISPOSABLE SET. THE GUIDE WARNS THE USER THAT CONNECTING THE TRANSFER SET TO THE PATIENT LINE BEFORE CONNECT YOURSELF APPEARS ON THE DISPLAY SCREEN MAY RESULT IN IIPV. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED.  IF ANY RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS DISCOVERED THAT THE CLAMPS WERE OPEN ON LINES WHILE THE HOME PATIENT (HP) WAS CONNECTED TO THE SETUP DURING THE LOAD SET STEP OF THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLOSE THE CLAMPS, DISCONNECT, CYCLE THE POWER ON THE HC MACHINE, AND REMOVE THE CASSETTE. THE HP STATED THAT THEY HAD AN INFECTION ON THEIR HAND AND IT HURT THEM TO USE IT. THE TSR ADVISED THE HP TO START THERAPY OVER USING NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330683 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE