BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3981891 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25403
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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, WHERE THE CUSTOMER DID NOT PRIME 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 STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT WARNS THE USER NOT TO CONNECT TO YOUR PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. IT ALSO PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY REPRIMING THE PATIENT LINE. 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

    IT WAS REPORTED THAT DURING PD THERAPY WITH AN AUTOMATED PD SET WITH CASSETTE THE HOME PATIENT (HP) FAILED TO FOLLOW THERAPY STEPS. THE HP STATED THAT THEY HAD CONNECTED TO THE HC WHILE IT WAS STILL PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458205 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE