BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3004028 · Received March 14, 2013

    Report

    Report Number
    1416980-2013-06109
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE EVENT WAS USE ERROR. THERE WAS NO REPORTED DEVICE MALFUNCTION; THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE LABELING INSTRUCTS THE PATIENT TO ENSURE ALL CLAMPS ARE CLOSED ON UNUSED LINES.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240, (AIR IN TUBING) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT THERE WERE NO LEAKS OR WET LINES. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED AND NO PATIENT EXTENSIONS WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE BAGS WERE PROPERLY CONNECTED AND THERE WAS AN OPEN CLAMP ON AN UNUSED LINE. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES, AND THEY HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THE TSR EXPLAINED THE ALARM AND CLEARED IT. THE TSR ADVISED THE HP TO CALL THE NURSE FOR FURTHER MEDICAL INSTRUCTIONS. THERE WAS A PATIENT INVOLVED, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107783 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE