BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3925369 · Received July 2, 2014

    Report

    Report Number
    2016493-2014-00316
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INITIALLY REQUESTED AN EVENT LOG REVIEW AND SUBMITTED LOGS AND DATASET FOR INVESTIGATION, HOWEVER, IT WAS DETERMINED THAT THEY WERE THE INCORRECT LOGS. SUBSEQUENTLY, THE CUSTOMER NOTIFIED US THAT THE LOGS WERE REVIEWED BY THEIR RISK MANAGEMENT, AND IT WAS DETERMINED THAT THE CARDIZEM WAS POWERED OFF BY THE USER. THE CUSTOMER DECLINED TO RETURN THE EVENT LOGS FROM THE EVENT PC UNIT, AND DECLINED AN EVENT LOG REVIEW OR ANY FURTHER INVESTIGATION BY CAREFUSION. THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDER INFUSION OF CARDIZEM. REPORTEDLY, THE PATIENT LEFT THE FLOOR TO GO TO RADIOLOGY WITH CARDIZEM INFUSION. HOWEVER, WHEN THE PATIENT WAS IN THE RADIOLOGY DEPARTMENT, THE STAFF FOUND THE CARDIZEM WAS NOT INFUSING AND THE PUMP WAS OFF. THE PATIENT DEVELOPED AN UNSPECIFIED "SHOCKABLE RHYTHM", THE CODE TEAM WAS CALLED, AND THE PATIENT WAS RESUSCITATED. NO ADDITIONAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CONDITION. CUSTOMER REQUESTS AND EVENT LOG REVIEW TO DETERMINE WHEN THE CARDIZEM WAS TURNED OFF AND IF IT WAS TURNED OFF BY THE USER OR SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385369 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE TUBING: MODEL/LOT UNK| ALARIS PC UNIT: SN UNK