BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4162076 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35264
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. HOWEVER, AN INCOMPLETE PRIME WAS REPORTED AND IS A KNOWN CAUSE OF THIS ALARM. ¿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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO DID NOT FOLLOW THERAPY STEPS DURING PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS CONNECTED TO THE HOMECHOICE PATIENT LINE BEFORE PRIMING WAS COMPLETE AND PRIOR TO THE ¿CONNECT YOURSELF¿ PROMPT. THE PATIENT WOULD CONTINUE THERAPY WITH ALL 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
    643340 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE