BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4150801 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-34965
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. HOWEVER, IT WAS REPORTED THAT THE HOME PATIENT CONNECTED TO AN IMPROPERLY PRIMED PATIENT LINE. 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. THE GUIDE INSTRUCTS THE USER TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED AND TO FOLLOW INSTRUCTIONS FOR RE-PRIMING IF THE FLUID LEVEL IS NOT NEAR THE CONNECTOR. 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

    DURING TROUBLESHOOTING OF AN UNRELATED ALARM, IT WAS REPORTED THAT AIR WAS OBSERVED IN THE PATIENT LINE OF THE CASSETTE. THE EVENT OCCURRED DURING THE INITIAL DRAIN ON THE HOMECHOICE (HC) AND THE HOME PATIENT (HP) WAS CONNECTED. THE CAREGIVER (CG) STATED THAT THE PATIENT LINE CLAMP WAS CLOSED, RESULTING IN AN IMPROPERLY PRIMED PATIENT LINE. THE HP HAD BEEN CONNECTED TO THE PATIENT LINE FOR THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO END THERAPY AND ADVISED THE CG TO START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632398 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE