BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 19030701 · Received April 3, 2024

    Report

    Report Number
    2016493-2024-21931
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    February 22, 2024
    Report Date
    April 23, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801549
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION: IF OTHER SPECIFY, IMDRF ANNEX A, G, B, C, D CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY THE CUSTOMER REPORTED PROGRAMMING ERROR OCCURRING IN ANESTHESIA MODE WAS NOT CONFIRMED. HOWEVER, A PROGRAMMING ERROR WAS OBSERVED IN NON-ANESTHESIA MODE. ¿ THE CUSTOMER REPORTED THE INCIDENT DATE AS 22 FEBRUARY 2024, HOWEVER NO TIME WAS REPORTED. USING THE PROVIDED INFORMATION A LIMITED SUMMARY OF THE INCIDENT INFUSION WAS PERFORMED AND IS LISTED BELOW. O ON 22 FEBRUARY 2024 AT 11:28 AM, AN INFUSION OF DEXMEDETOMIDINE DRIP WITH A DOSE OF 105MCG/KG/H (118.1ML/H) WAS OBSERVED TO BE STARTED AFTER THE USER SELECTED YES TO THE GUARDRAILS ALERT ¿DOSE OF 105MCG/KG/H EXCEEDS GUARDRAILS LIMIT OF 2MCG/KG/H. PROCEED?¿. O THE INFUSION CONTINUED AT THIS RATE FOR APPROXIMATELY FOURTEEN (14) MINUTES BEFORE THE DOSE WAS CHANGED TO 1MCG/KG/H. ¿ THE CUSTOMER PROVIDED INFORMATION WAS USED AND THE FOLLOWING OBSERVATIONS WERE MADE. O THE SYSTEM WAS NOT IN ANESTHESIA MODE AT THE TIME OF THE INCIDENT, SINCE THE INCIDENT DRUG DID NOT START WITH THE NOTED ¿A-¿AT THE START OF THE DRUG NAME O (A-DEXMEDETOMIDINE). O THE SYRINGE MODULE WAS PROGRAMMED AS A DEXMEDETOMIDINE DRIP. O THE DATA SET WAS EVALUATED USING GUARDRAILS EDITOR V12.1.2 AND IT WAS DETERMINED THAT THE DATASET DID NOT CONTAIN HARD MAX LIMIT IN NON-ANESTHESIA MODE FOR DEXMEDETOMIDINE DRIP INFUSION. O USING GUARDRAILS EDITOR V12.1.2 THE PROVIDED DATA SET WAS UPDATED TO INCLUDE A HARD MAX LIMIT OF 2.5MCG/KG/H TO THE DEXMEDETOMIDINE DRIP. AFTER A HARD MAX LIMIT WAS SET TO THE NON-ANESTHESIA VERSION OF THE DRUG (DEXMEDETOMIDINE DRIP), THE EXPECTED HARD LIMIT ALERT WAS OBSERVED. ¿ INFUSING WITH THE SYSTEM SET TO ANESTHESIA MODE ENABLED CONFIRMED THAT THERE WAS NO HARD LIMITS. ¿ NO TESTING OR INSPECTION WAS ABLE TO BE PERFORMED DUE TO NO DEVICES BEING RETURNED FOR INVESTIGATION. H3 OTHER TEXT : NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGRAMMING ERROR BY "ANESTHESIOLOGIST" WHERE PRECEDEX 1.5MCG/KG/HR. WAS PROGRAMMED AS 105MCG/KG/HR." AND THE INFUSION REPORTEDLY RAN AT THIS RATE FOR "SEVERAL MINUTES." AS A RESULT, THE PATIENT HAD HYPOTENSION AND BRADYCARDIA. THE PATIENT RECEIVED FLUID BOLUSES (X2) AND THE REPORTEDLY "BECAME STABLE." DUE TO THE EVENT, THE CUSTOMER IS REQUESTING THE MANUFACTURER TO HAVE HARD GUARDRAILS¿ LIMITS WHILE THE DEVICE IS IN ANESTHESIA MODE. A HARD LIMIT IS A PROGRAMMED LIMIT THAT CANNOT BE OVERRIDDEN. CURRENTLY, HARD GUARDRAILS¿ LIMITS ARE RE-ESTABLISHED WHEN ANESTHESIA MODE IS DISABLED, BOTH FOR EXISTING INFUSIONS AND NEW INFUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGRAMMING ERROR BY "ANESTHESIOLOGIST" WHERE PRECEDEX 1.5MCG/KG/HR. WAS PROGRAMMED AS 105MCG/KG/HR." AND THE INFUSION REPORTEDLY RAN AT THIS RATE FOR "SEVERAL MINUTES." AS A RESULT, THE PATIENT HAD HYPOTENSION AND BRADYCARDIA. THE PATIENT RECEIVED FLUID BOLUSES (X2) AND THE REPORTEDLY "BECAME STABLE." DUE TO THE EVENT, THE CUSTOMER IS REQUESTING THE MANUFACTURER TO HAVE HARD GUARDRAILS¿ LIMITS WHILE THE DEVICE IS IN ANESTHESIA MODE. A HARD LIMIT IS A PROGRAMMED LIMIT THAT CANNOT BE OVERRIDDEN. CURRENTLY, HARD GUARDRAILS¿ LIMITS ARE RE-ESTABLISHED WHEN ANESTHESIA MODE IS DISABLED, BOTH FOR EXISTING INFUSIONS AND NEW INFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783160 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801549

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Required Intervention