BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3061688 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09409
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD NOT BEEN PROPERLY PRIMED. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. THE BAGS WERE PROPERLY CONNECTED AND THERE WAS 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 CAREGIVER (CG) STATED A CLAMP WAS CLOSED ON THE DRAIN LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE PATIENT LINE NEEDED TO BE PRIMED ALL THE WAY BEFORE CONNECTING TO CONTINUE THRERAPY AND ANY CLAMPS THAT WERE ON THE LINES THAT WERE BEING USED MUST BE OPEN. THE TSR ADVISED THE HOME PATIENT (HP) TO START OVER WITH NEW SUPPLIES AND TO CONTACT THE REGISTERED NURSE (RN) ABOUT POSSIBLE INTRODUCTION OF AIR IN THE LINES. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT 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
    162980 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE