BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE

    MDR report key: 8663323 · Received June 3, 2019

    Report

    Report Number
    2016493-2019-00599
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 15, 2019
    Report Date
    May 15, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE SYRINGE MODULE ALARMING NEAR END INFUSION WAS NOT CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN GOOD CONDITION. REVIEW OF THE EVENT LOG SHOWS THERE WAS SIMILAR USE RECORDED AT THE END OF MAR/2019 AFTER A MULTI-DAY INFUSION. THE SYRINGE MODULE WAS ONE OF 4 MODULES ATTACHED TO THE PC UNIT ON 28/MAR/2019 AT 10:19PM. THE FOUR PUMP MODULES WERE PROGRAMMED FOR MULTI-STEP INFUSIONS WITH DIFFERENT RATES, VTBIS AND NUMBER OF STEPS. THE INFUSIONS ALL RAN WITHOUT ISSUES UNTIL (B)(6) 2019 ALTHOUGH MULTIPLE NEAR END OF INFUSION ALARMS WERE RECORDED AFTER WHICH THE SYRINGE WAS REPLACED AND THE INFUSION WAS RESTARTED. AT 05:44PM SYRINGE MODULE S/N: (B)(4) HAD ALARMED FOR NEAR END OF INFUSION AFTER BEING PROGRAMMED TO INFUSE 0.5ML AT 6ML/H. THE PUMP HAD INFUSED A TOTAL OF 550.954ML. THE INFUSION WAS PAUSED AT 05:44PM AND A NEW SYRINGE WITH A VOLUME OF 51.634ML WAS LOADED AT 05:44PM. THE INFUSION WAS RESUMED WITH A VTBI OF 0.3556ML AND A RATE OF 6ML/H AT 05:44:53PM AND THEN ALARMED FOR NEAR END OF INFUSION AT 05:48PM WITH 0.1185ML LEFT TO BE INFUSED. THE INFUSION WAS STOPPED AT 05:49:15PM AND A SYRINGE WAS CONFIRMED AT 05:49:35PM. A 6ML/H INFUSION WAS STARTED AT 05:49:44PM. THE INFUSION WAS STOPPED, AND THE PUMP WAS POWERED OFF AT 05:50PM. THE ISSUE SEEMS TO BE WITH THE USER SETTINGS RATHER THAN ANY FAULT WITH EITHER THE PUMP OR PCU. TESTING CONFIRMED THAT WHEN A SYRINGE HAS INFUSED THE VOLUME OF AN INSERTED SYRINGE AND INSERTING A NEW SYRINGE THE PUMP WILL ASK YOU TO ENTER A NEW VTBI. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT WAS DUE TO USER ERROR.

    Description of Event or Problem · 0

    THE REPORTED FEEDBACK SUGGESTS THAT THE SYRINGE MODULE ALARMING NEAR END INFUSION. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE REPORTED FEEDBACK SUGGESTS THAT THE SYRINGE MODULE ALARMING NEAR END INFUSION. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457631 ALARIS SYRINGE MODULE PUMP, INFUSION FRN CAREFUSION 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 8015, THERAPY DATE (B)(6) 2019.