BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4812802 · Received June 2, 2015

    Report

    Report Number
    2016493-2015-00387
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 5, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A REPORTED OVER INFUSION OF LEVOPHED (NOREPINEPHRINE) WAS NOT CONFIRMED. NO DEVICE OR ADMINISTRATION SET WAS RETURNED FOR INVESTIGATION. THE PC UNIT EVENT LOG SHOWS THAT THE PC UNIT WAS POWERED ON (B)(6) 2015 AT 4:13 PM. THE PUMP MODULE WAS ATTACHED AS CHANNEL B. AT 8:09 PM HIGH DOSE (29 ¿ 60 MCG/MIN) NOREPINEPHRINE (DRUG ID 269) WAS PROGRAMMED USING GUARDRAILS DRUG LIBRARY AS A PRIMARY INFUSION. THE USER ENTERED A DOSE OF 2MCG/MIN (RATE 3.75 ML/HR) AND A VOLUME TO BE INFUSED (VTBI) OF 200 ML. A SOFT GUARDRAILS ALERT OCCURRED DUE TO THE DOSE OF 2MCG/MIN BEING BELOW THE GUARDRAILS LIMIT OF 29MCG/MIN. THE USER SELECTED YES TO CONTINUE WITH THE INFUSION AT A RATE OF 3.75 ML/HR. AT 8:11 PM, THE USER PAUSED THE PUMP MODULE AND THEN QUICKLY RESTARTED THE INFUSION. AT 8:12 PM THE USER POWERED OFF THE PUMP MODULE WITH A PRIMARY VOLUME INFUSED (PVI) OF 0.162 ML. AT 9:03 PM, THE USER RESTORED THE PREVIOUS PROGRAMMED PARAMETERS, SELECTED YES TO THE SAME GUARDRAILS SOFT ALERT, AND BEGAN THE INFUSION AT A RATE OF 3.75 ML/HR WITH A VTBI OF 199.838 ML. AT 9:05 PM THE USER POWERED OFF THE PUMP MODULE WITH A PVI OF 0.312 ML. AT 9:29 PM THE USER RESTORED THE PREVIOUS PROGRAMMING PARAMETERS, SELECTED YES TO THE GUARDRAILS SOFT ALERT, AND BEGAN THE INFUSION AT A RATE OF 3.75 ML/HR WITH A VTBI OF 199.688 ML. LESS THAN A MINUTE LATER THE USER POWERED OFF THE PUMP MODULE WITH A PVI OF 0.316 ML. THE ROOT CAUSE OF THE REPORTED OVER INFUSION OF LEVOPHED (NOREPINEPHRINE) WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    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. DEVICES NOT RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LEVOPHED 8MG/250ML PRIMARY INFUSION WAS SHUT OFF, BUT FLUID WAS STILL DRIPPING INTO DRIP CHAMBER. THE FLUID WAS FLOWING DESPITE THE TUBING STILL BEING LOADED IN THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354282 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 8015, PRI TUBING