BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3983727 · Received June 25, 2014

    Report

    Report Number
    2016493-2014-00319
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: JUNE 25, 2014. (B)(4). NO PRODUCT RETURN IS EXPECTED. THE DELAY FEATURE IS A PROGRAMMABLE FEATURE AND NO MALFUNCTION OF THE DEVICE IS BELIEVED TO HAVE OCCURRED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS A DIPRIVAN INFUSION IN THE PACU RESTARTED UNEXPECTEDLY AFTER A SOFTWARE CHANGE BECAUSE THE DELAY START FEATURE ON THE DATA SET DEFAULTED TO "AFTER" INSTEAD OF "BEFORE AND AFTER" LIKE AS IT WAS PREVIOUSLY. THE NURSES WERE EXPECTING NOTIFICATION WHEN THE MEDICATION WAS TO RESTART BUT IT DID NOT; THE DIPRIVAN INFUSION STARTED ON ITS OWN ON AN EXTUBATED PATIENT. THE NURSES WERE QUICK TO NOTICE IT, AND WERE ABLE TO STOP THE INFUSION SHORTLY AFTER IT HAD STARTED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371054 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 THERAPY DATE:| ALARIS PC UNIT SN UNKNOWN,| ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNKNOWN