BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® SYRINGE MODULE

    MDR report key: 6024568 · Received October 12, 2016

    Report

    Report Number
    2016493-2016-00769
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 21, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A CHANNEL ERROR DURING TRANSPORT WAS CONFIRMED IN THE SYRINGE MODULE DEVICE LOGS. THERE WERE NO ANOMALIES OBSERVED WITH THE RECEIVED SUSPECT SYRINGE MODULE. THE SYRINGE MODULE ERROR LOG SHOWS A CHANNEL ERROR CODE 13-1033-149 OCCURRED AT 12:16:56 PM ON (B)(6) 2016. THE ROOT CAUSE OF THE CHANNEL ERROR DURING TRANSPORT WAS IDENTIFIED AS SOFTWARE RELATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING TRANSPORT, NOREPINEPHRINE 0.032 MG/ML IN A 60 ML BD SYRINGE, PROGRAMMED USING THE ¿PICU GREATER THAN (B)(6)¿ PROFILE, WAS INFUSING AT 0.15 MCG/KG/MIN (5.63 ML/HR). THE DEVICE ALARMED FOR AN UNSPECIFIED CHANNEL ERROR AND THE CHANNEL SHUT OFF. THE PATIENT BECAME HYPOTENSIVE AND FLUID RESUSCITATION WAS PROVIDED WHILE A NEW SYRINGE MODULE WAS OBTAINED AND THE INFUSION WAS RESTARTED. THE PATIENT¿S BLOOD PRESSURE STABILIZED. NO OTHER INFORMATION ABOUT THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672505 ALARIS® SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention SPM TUBING,8015, TD