BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 3862977 · Received June 4, 2014

    Report

    Report Number
    2016493-2014-00254
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATA SET, DEVICE LOGS AND SYRINGE MODULE HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION OF LIPIDS IN THE NICU. A 60 ML SYRINGE CONTAINING 52 ML LIPIDS WAS INSTALLED AT AROUND 4 PM ON (B)(6) 2014 TO "INFUSE ALL" AT THE RATE OF ABOUT 2.2 ML/HR AND WAS EXPECTED TO LAST ABOUT 24 HOURS. THE SYRINGE WAS DISCOVERED TO BE EMPTY AT AROUND 5 AM ON (B)(6) 2014. TRIGLYCERIDE LEVEL WAS DRAWN AND THE LEVEL WAS REPORTED TO BE HIGH (SPECIFIC LEVEL NOT PROVIDED). OTHER THAN THE ELEVATED TRIGLYCERIDES, THE PT HAD NO ADVERSE EFFECT AND IS CURRENTLY DOING WELL. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326122 ALARIS SYRINGE MODULE SYRINGE PUMP FRN CAREFUSION CORP 8110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT, SN (B)(4)| EXTENSION TUBING SET, MFR/MODEL/LOT UNK