BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2841093 · Received November 20, 2012

    Report

    Report Number
    1416980-2012-05693
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 4, 2012
    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 FOR A REPORT OF A SYSTEM ERROR 2240 WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR - OPEN CLAMP. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN TUBING) AND SYSTEM ERROR 2367 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 3 OF 5. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THE PATIENT LINE HAD BEEN PROPERLY PRIMED PRIOR TO CONNECTING AND NO PATIENT EXTENSIONS WERE IN USE. THE PATIENT HAD NOT DISCONNECTED PRIOR TO THE ALARM. ALL OF THE BAGS WERE PROPERLY CONNECTED. THE SUPPLIES HAD NOT BEEN DAMAGED BY AN OUTLET PORT CLAMP OR ASSIST DEVICE. THERE WAS AN OPEN CLAMP ON AN UNUSED LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MESSAGE TO THE REGISTERED NURSE (RN) AND ADVISED TO USE MANUAL BAGS TOP COMPLETE THERAPY. THE RN STATED THAT SHE DID NOT HAVE ANY TO USE. THE TSR ADVISED THE RN TO LET THE PATIENT'S PERITONEAL DIALYSIS RN KNOW ABOUT THE ISSUE. PROPER PROCEDURES WERE REVIEWED, AND THERE WERE NO SAMPLES AVAILABLE. THE LOT NUMBER WAS NOT AVAILABLE. THE HC WAS OKAY. 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
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR HOMECHOICE