BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1882479 · Received October 21, 2010

    Report

    Report Number
    9616066-2010-00304
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 10/20/2010. (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE CUSTOMER REPORTED 4 POSSIBLE LOTS: 10066437, 10075502, 10045282, 10065052. THE REPORT OF A LEAK IN THE SET WAS CONFIRMED. A CLEAN SLICE HOLE WAS NOTED IN THE TUBING ABOUT 9 INCHES BELOW THE DRIP CHAMBER. ANY CRUSH MARKS AROUND THE HOLE COULD NOT BE IDENTIFIED DUE TO ADHESIVE RESIDUE FROM TAPE THE USER APPLIED TO MARK THE LOCATION. ROOT CAUSE OF THE SLICE COULD NOT BE IDENTIFIED AND IT CAN NOT BE DETERMINED IF THE SLICE ORIGINATED IN THE MANUFACTURING PROCESS OR AFTER THE SET ARRIVED AT THE CUSTOMER SITE. LOT NUMBER WAS NOT REPORTED. A SEARCH OF THE DATA BASE SHOWED NO QUALITY ISSUES FOR THE 4 POSSIBLE LOT NUMBERS INDICATED ABOVE, AND ONE RELATED QUALITY ISSUE FOR THIS TUBING COMPONENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE NURSE BEGAN AN INFUSION AND IV FLUID SPRAYED FROM A HOLE IN THE TUBING. NO PATIENT HARM. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2126-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK