BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4253716 · Received November 16, 2014

    Report

    Report Number
    1416980-2014-40858
    Event Type
    Malfunction
    Date Received
    November 16, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. HOWEVER, IMPROPERLY DISCONNECTING FROM THE SET IS A KNOWN CAUSE OF THIS ISSUE. 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 HAS INSTRUCTIONS ON THE STEPS TO PROPERLY DISCONNECT FROM CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT FOR THERAPY AFTER PROPERLY DISCONNECTING. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF AN UNRELATED ALARM, IT WAS REPORTED THAT A PATIENT EXPERIENCED AIR IN THE PATIENT LINE OF A HOMECHOICE CASSETTE. THE PATIENT WAS CONNECTED AT THE TIME THE AIR WAS DISCOVERED. THIS OCCURRED DURING FILL ONE OF PERITONEAL DIALYSIS THERAPY. THE HOME PATIENT IMPROPERLY DISCONNECTED FROM THE SET UP THEN RECONNECTED. THE TECHNICAL SERVICES REPRESENTATIVE REVIEWED PROPER PROCEDURES WITH THE PATIENT AND ASSISTED THE PATIENT TO END THERAPY. THE PATIENT WOULD COMPLETE THERAPY BY STARTING OVER WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740956 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR HOMECHOICE