BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2944324 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02979
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A LEAK FROM DISPOSABLE SET IS CONFIRMED BECAUSE IT WAS REPORTED BY CARE GIVER THAT WHILE TRYING TO BYPASS TO END THE THERAPY, WHEN THE CYCLER WAS IN FILL 5 OF 5, THE PATIENT DISCONNECTED WITHOUT FOLLOWING PROPER EMERGENCY DISCONNECT PROCEDURE CAUSING FLUID TO LEAK OUT OF THE PATIENT LINE, WHICH IS A USE ERROR AND CAN CAUSE POTENTIAL CONTAMINATION. THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THE HOME CHOICE (HC)WAS IN FILL 5 OF 5, THE CAREGIVER (CG) COULD NOT BYPASS TO END THERAPY AND STATED THE HOME PATIENT (HP) WAS NOT CONNECTED AND THE HC KEPT SHOOTING SOLUTION OUT OF THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED THE CG IF THE HC ALARMED AND THE CG STATED NO. THE CG STATED, SHE WAS TRYING TO BYPASSING TO END THE THERAPY. THE TSR HAD THE CG CLOSE THE CLAMPS AND CYCLE THE POWER. THE HC ALARMED POWER RESTORED/ FILL 5 OF 5. THE TSR REVIEWED THE FILL VOLUME (FV)= 1746ML. THE TSR ASSISTED WITH ENDING THE THERAPY AND GETTING THE SET OUT. THE TSR RECOMMENDED THE CG CONTACT THE REGISTERED NURSE (RN) ABOUT THE HP DISCONNECTING EARLY. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48298 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOMECHOICE