BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYRINGE PUMP MODULE

    MDR report key: 3843588 · Received May 21, 2014

    Report

    Report Number
    2016493-2014-00259
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MORPHINE OVER INFUSION IN THE NICU. THE ORDERED RATE WAS 0.16ML/HR, BUT 1.5 HRS INTO THE INFUSION THE RATE WAS NOTED TO BE AT 16ML/HR. THE PT REQUIRED MORE FREQUENT MONITORING AND ADDITIONAL BLOOD WORK. THE PT IS CURRENTLY STABLE AND STILL IN THE NICU. CUSTOMER REQUESTS EVENT LOG REVIEW FOR PROGRAMMING, VOLUME INFUSED, AND ALARMS DURING INFUSION. NO FURTHER PT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303408 ALARIS SYRINGE PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 DA Required Intervention ALARIS PC UNIT SN (B)(4),| SYRINGE, MFR/MODEL/LOT UNK