BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4171316 · Received October 14, 2014

    Report

    Report Number
    1416980-2014-35863
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 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). THIS COMPLAINT IS A REPORT OF USE ERROR OF THE PATIENT NOT FOLLOWING PROPER DISCONNECT AND RECONNECT PROCEDURES. 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 DISCONNECTING DURING EMERGENCIES AND PROVIDES STEP-BY-STEP INSTRUCTIONS FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. THE GUIDE ALSO WARNS THE USER THAT THE EMERGENCY DISCONNECT PROCEDURE IS INTENDED FOR EMERGENCY DISCONNECTION FOR SHORT PERIODS OF TIME ONLY. EXTENDED TIME AWAY FROM THE SYSTEM DURING THERAPY CAN RESULT IN LOST DWELL TIME. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD THE DEVICE BE RETURNED OR ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) FAILED TO FOLLOW THERAPY STEPS ON THE HOMECHOICE DEVICE, DURING DWELL. THE CARE GIVER (CG) STATED SHE FORGOT TO SET THE TIMER FOR 2 HOURS AND WHEN SHE WENT BACK IN TO HOOK THE HP UP AFTER THE DWELL, THE MACHINE HAD ALREADY STARTED DRAINING. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT UNSTERILE AIR MAY HAVE ENTERED THE SET UP AND COMPROMISED IT, AND RECOMMENDED THE CG STOP THERAPY AND START OVER WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650188 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1