BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1833448 · Received September 8, 2010

    Report

    Report Number
    9616066-2010-00254
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 26, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K934095
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATED AND CUSTOMER'S EXPERIENCE OF A DISCONNECT AT THE WHITE SYRINGE CONNECTION WAS CONFIRMED. THE DISCONNECT WAS OBSERVED TO BE BETWEEN THE WHITE SPIKE AND THE UPPER FITMENT. THE CAUSE OF THE DISCONNECTION WAS IDENTIFIED AS INSUFFICIENT SOLVENT APPLIED AT THIS ENGAGEMENT DURING THE MANUFACTURING PROCESS. THE LOT NUMBER WAS NOT IDENTIFIED, THEREFORE, LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCONNECTION AT POINT BETWEEN WHITE SYRINGE CONNECTOR AND BODY OF LINE. THE SET DISCONNECT OCCURRED WHEN REMOVING FROM THE PUMP AND NO TORQUE OCCURRED. SET WAS CONNECTED TO 60ML SYRINGE, POSSIBLY LIPIDS INFUSION, BUT NOT CONFIRMED. NO PROBLEMS WITH AIR-IN-LINE (AIL) ALARMS OR AIL NOTED. NO PATIENT HARM REPORTED. 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 10010483 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE, SERIAL # UNKNOWN