BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3863566 · Received June 10, 2014

    Report

    Report Number
    1416980-2014-18496
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 18, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAREGIVER REPORTED THAT THE PATIENT HAD BEEN CONNECTED TO THE PATIENT LINE DURING PRIMING. 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 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. 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 INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE GUIDE WARNS THE USER TO THAT CONNECTING YOURSELF BEFORE CONNECT YOURSELF APPEARS CAN CAUSE AIR TO BE DELIVERED TO THE PERITONEAL CAVITY. 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, THE CAREGIVER (CG) STATED THAT THE PATIENT HAD BEEN CONNECTED TO THE SETUP DURING PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED PROPER PROCEDURES WITH THE CG AND ASSISTED THE CG IN ENDING THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338041 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE