BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 20000510 · Received August 20, 2024

    Report

    Report Number
    2016493-2024-34190
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    May 3, 2024
    Report Date
    August 28, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810039
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: C20 NO FINDINGS AVAILABLE, D15 CAUSE NOT ESTABLISHED. CORRECTION: DESCRIBE EVENT OR PROBLEM, UNIQUE IDENTIFIER (UDI) # ADDITIONAL INFORMATION: 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 REPORTED ISSUE THAT THERE WAS AN INACCURATE DELIVERY OF NOREPINEPHRINE WAS CONFIRMED THROUGH A REVIEW OF THE RECEIVED INFUSION KNOWLEDGE PORTAL (IKP) REPORT (NOT VALIDATED FOR LOG ANALYSIS PURPOSES). THE IKP REPORT SHOWED THAT THE INFUSION OF NOREPINEPHRINE AT 8MG/250ML WAS STARTED WITH THE DOSE AT 0.100 MCG/KG/MIN (RATE=39.5ML/H) ON THE DATE 03MAY2024 AT THE TIME OF 12:45 AM. THE NOREPINEPHRINE INFUSION INFUSED A CALCULATED VOLUME OF 20.6ML WHILE AT THE DOSE OF 0.100 MCG/KG/MIN BEFORE THE DOSE WAS INCREASED IN ERROR TO THE VALUE OF 1 20 MCG/KG/MIN (RATE=474.5ML/H) AT THE TIME OF 1:21 AM THE VOLUME INFUSED CALCULATION WAS DERIVED FROM SUBTRACTING THE VOLUME (83 5ML) AT THE START OF THE INFUSION FROM THE TOTAL VALUE WHEN THE DOSE WAS CHANGED (104 1ML). THE NOREPINEPHRINE INFUSION DOSE WAS DECREASED TO THE INTENDED DOSE OF 0.120 MCG/KG/MIN (RATE=47 5ML/H) AT THE TIME OF 1:27 AM. THE NOREPINEPHRINE INFUSION INFUSED A CALCULATED VOLUME OF 49.2ML WHILE AT THE UNINTENDED DOSE OF 1.20 MCG/KG/MIN. THIS VALUE WAS DERIVED BY SUBTRACTING THE VOLUME (104.1 ML) AT THE START OF THE INFUSION FROM THE TOTAL VALUE WHEN THE DOSE WAS CHANGED TO THE INTENDED DOSE OF 0.120 MCG/KG/MIN (153.3ML) THE RECEIVED DATA SET (JHBMC 01-30-2024) SHOWED THE SOFT GUARDRAILS SETTING FOR NOREPINEPHRINE IN THE CRITICAL CARE PROFILE WAS SET AT 3 MCG/KG/MIN WITH THE HARD MAX SETTING AT 3.1 MCG/KG/MIN. THE PROGRAMMING ERROR AT 1.20 MCG/KG/MIN DID NOT VIOLATE THE GUARDRAILS SETTINGS. NO DEVICES OR THE ASSOCIATED DEVICE LOGS WERE PROVIDED BY THE FACILITY FOR FURTHER INVESTIGATION THE FACILITY DECLINED A FURTHER INVESTIGATION. ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE OF AN INACCURATE DELIVERY OF NOREPINEPHRINE WAS CONFIRMED AND IS ATTRIBUTED TO USER PROGRAMMING BASED ON THE RECORDED DATA WITHIN THE RECEIVED INFUSION KNOWLEDGE PORTAL (IKP) REPORT. NO DEVICE MALFUNCTION WAS ALLEGED TO HAVE OCCURRED AND THERE WAS NO GUARDRAILS VIOLATION RECORDED WITHIN THE IKP REPORT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING 0.1 MCG/KG/MIN OF NOREPINEPHRINE 8 MG/250 ML. THE PATIENT HAD A MEAN ARTERIAL PRESSURE (MAP) OF 60 AND A HEART RATE OF 49. THE NURSE ASKED ANOTHER NURSE TO INCREASE THE DOSE TO 0.12 MCG/KG/MIN, HOWEVER THE SECOND NURSE CHANGED THE DOSE TO 1.2 MCG/KG/MIN. AFTER ABOUT 8 MINUTES, THE PATIENT HAD CHEST PAIN, ELEVATED TROPONINS, A NEW MAP OF 124, AND THE "EKH" SHOWED VENTRICULAR TACHYCARDIA AND A STEMI. THE NOREPINEPHRINE WAS STOPPED, AND THE PATIENT RETURNED TO BASELINE AFTER ABOUT 10 MINUTES. THE CUSTOMER WAS ALSO REQUESTING TO ADD THE CAPABILITY FOR ALARIS GUARDRAIL ALERTS TO APPEAR FOR RELATIVE CHANGES IN DOSE OR INFUSION RATE. THE CUSTOMER LATER ADDED THAT NO ADDITIONAL MEDICAL INTERVENTIONS WERE PROVIDED, AND THE PATIENT RECOVERED NATURALLY AFTER MONITORING. AFTER THE PATIENT ISSUE RESOLVED, THE NOREPINEPHRINE WAS RESUMED AT 0.12 MCG/KG/MIN. IT WAS ALSO MENTIONED THAT THERE WAS A HEPARIN INFUSION RUNNING AT THE TIME OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING 0.1 MCG/KG/MIN OF NOREPINEPHRINE 8 MG/250 ML. THE PATIENT HAD A MEAN ARTERIAL PRESSURE (MAP) OF 60 AND A HEART RATE OF 49. THE NURSE ASKED ANOTHER NURSE TO INCREASE THE DOSE TO 0.12 MCG/KG/MIN, HOWEVER THE SECOND NURSE CHANGED THE DOSE TO 1.2 MCG/KG/MIN. AFTER ABOUT 8 MINUTES, THE PATIENT HAD CHEST PAIN, ELEVATED TROPONINS, A NEW MAP OF 124, AND THE "EKH" SHOWED VENTRICULAR TACHYCARDIA AND A STEMI. THE NOREPINEPHRINE WAS STOPPED AND THE PATIENT RETURNED TO BASELINE AFTER ABOUT 10 MINUTES. THE CUSTOMER WAS ALSO REQUESTING TO ADD THE CAPABILITY FOR ALARIS GUARDRAIL ALERTS TO APPEAR FOR RELATIVE CHANGES IN DOSE OR INFUSION RATE. THE CUSTOMER LATER ADDED THAT NO ADDITIONAL MEDICAL INTERVENTIONS WERE PROVIDED AND THE PATIENT RECOVERED NATURALLY AFTER MONITORING. AFTER THE PATIENT ISSUE RESOLVED, THE NOREPINEPHRINE WAS RESUMED AT 0.12 MCG/KG/MIN. IT WAS ALSO MENTIONED THAT THERE WAS A HEPARIN INFUSION RUNNING AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2395930 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention