BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE HORIZON PUMP IV SET

    MDR report key: 623840 · Received July 20, 2005

    Report

    Report Number
    623840
    Event Type
    Malfunction
    Date Received
    July 20, 2005
    Date of Event
    July 18, 2005
    Report Date
    July 20, 2005
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE CAPA IS STILL IN PROCESS; HOWEVER, THE FOLLOWING ACTIONS ARE BEING EVALUATED BY THE MANUFACTURER, OPERATORS WILL BE ALERTED TO THE FOLLOWING: FINAL ASSEMBLY: OPERATORS SHOULD COIL UNITS PER "COILING BOOK" INSTRUCTIONS. PACKAGING CLEAN ROOM: OPERATORS SHOULD AVOID MISPLACED UNITS. PACKAGING GRAY AREA: OPERATORS SHOULD INSPECT UNITS FOR SET INTEGRITY. ALL BURNED UNITS SHOULD BE CUT AT GREY AREA AND REJECTED IMMEDIATELY. NONE OF THE BURNED UNITS SHOULD BE RECYCLED TO FFS AT THE CLEAN ROOM. EVALUATE THE FORM FILL AND SEAL MACHINE SPEED BY FLEX SIZE TO DETERMINE IF IT IS ACCORDING TO THE STANDARD TIME ESTABLISHED BY ENGINEERING. DATA WILL BE COLLECTED DURING SEPTEMBER AND OCTOBER MONTHS FOR ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    WHEN THE B BRAUN 3140 ULTRASITE HORIZON PUMP IV SET WAS OPEN BY THE NURSE, THE TUBING WAS CUT COMPLETELY INTO.

    Description of Event or Problem · 1

    ONE SAMPLE WAS RETURNED FOR EVALUATION, WHICH WAS SEVERED IN TWO PIECES. AFTER EXAMINATION, IT WAS DETERMINED THAT THIS DEFECT WAS A RESULT OF THE TUBING BEING CAUGHT IN THE SEAL AT THE TIME THE PRODUCT WAS PACKAGED. A LOT NUMBER WAS NOT PROVIDED SO A COMPLETE HISTORICAL REVIEW COULD NOT BE PERFORMED. HOWEVER, DUE TO REPORTS OF THIS NATURE AGAINST OTHER PRODUCTS, A CORRECTIVE ACTION/PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED IN CO'S FACILITY TO ADDRESS THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASITE HORIZON PUMP IV SET IV PUMP SET FPK B. BRAUN MEDICAL, INC. US3140 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *