BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3200096 · Received July 1, 2013

    Report

    Report Number
    1416980-2013-16916
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. THE PATIENT DISCONNECTED WITHOUT USING PROPER PROCEDURES, THEN RECONNECTED. THIS IS A KNOWN CAUSE OF THIS ALARM. 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 FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERITONEAL DIALYSIS (PD), A SYSTEM ERROR (SE) 2240 ALARM (AIR IN LINE) OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING USE. THE HOME PATIENT (HP) WAS NOT CONNECTED AT THE TIME OF THE ALARM. THE HP HAD DISCONNECTED PRIOR TO THE ALARM WITHOUT FOLLOWING THE PROPER PROCEDURE. THE HP THEN RECONNECTED AFTER THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED AND NO PATIENT EXTENSIONS WERE IN USE. THE BAGS WERE PROPERLY CONNECTED AND THERE WERE NOT ANY OPEN CLAMPS ON ANY UNUSED LINES. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES, AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE ALL CLAMPS. THE HP CYCLED THE POWER OFF AND ON TO CLEAR THE SE 2240 FOLLOWED BY A SE 2367 (FAIL SAFE SHUT DOWN) ENDING THERAPY. THE TSR HAD THE HP DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE CASSETTE. THE HP WAS INSTRUCTED TO NOTIFY THEIR PD NURSE OF MISSED THERAPY. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299243 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE