BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 14515965 · Received May 26, 2022

    Report

    Report Number
    2016493-2022-148695
    Event Type
    Death
    Date Received
    May 26, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 16, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM, IMDRF ANNEX A, B AND G 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FENTANYL 25 MICROGRAMS/KG WAS BEING INFUSED DURING A BRONCHOSCOPY. THE CLINICIAN THEN GAVE A BOLUS DOSE OF 50 MICROGRAMS/KG. FOLLOWING THIS, THE PATIENT WENT INTO CARDIAC ARREST. SUBSEQUENTLY, THE CLINICIAN STOPPED THE FENTANYL INFUSION AND RAN SALINE, HOWEVER THE SALINE STOPPED ON ITS OWN AND RAN THE FENTANYL BACK IN OVER AN HOUR. ALTHOUGH MULTIPLE REQUESTS WERE MADE, NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT 1007 FENTANYL BOLUS 50MCG WAS GIVEN PRIOR TO SCHEDULED BRONCHOSCOPY. FOLLOWING BOLUS DOES, FENTANYL WAS PROGRAMMED TO INFUSE AT 25 MCG/HR = 2.5ML/HR AT 1008. AT 1039 PATIENT WENT INTO CARDIAC ARREST, ACLS STARTED AT 1039. FENTANYL INFUSION WAS STOPPED. FENTANYL MEDICATION AND TUBING WAS SUBSEQUENTLY REMOVED FROM THE PUMP MODULE AT 1120. AT THAT TIME A NORMAL SALINE BOLUS WAS HUNG ON SAME PUMP MODULE PREVIOUSLY INFUSING FENTANYL. AT 1230 FOLLOWING NORMAL SALINE BOLUS, FENTANYL MEDIATION AND TUBING WAS PLACED BACK INTO PUMP MODULE AND PROGRAMMED TO RESUME INFUSING AT 25 MCG/HR = 2.5ML/HR. IT WAS NOTED HOWEVER AT 1330 THE FENTANYL INFUSION WAS ALARMING AIR IN LINE. CHAMBER AND BAG CHECKED AND NOTED TO BE EMPTY. PATIENT WAS ALREADY INTUBATED. VITAL SIGNS WERE MONITORED. THE FOLLOWING DAY, THE PATIENT PASSED AWAY. IT WAS UNABLE TO BE DETERMINED BY THE CUSTOMER IF EVENT CAUSED OR CONTRIBUTED TO PATIENT DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE SETTING UP THE PATIENT ROOM AT FOR A CENTRAL LINE PLACEMENT, THE PUMP MODULE INFUSING PROPOFOL WAS BUMPED INTO. THE PROPOFOL PUMP MODULE ALARMED FOR A COMMUNICATION ERROR. THE CLINICIAN THEN MOVED THE PROPOFOL INFUSION FROM CHANNEL D TO CHANNEL A AND REPROGRAMMED INFUSION TO RUN AT 30MCG/KG/MIN WITHOUT ISSUE TO ALLOW FOR INCREASE SEDATION DURING CENTRAL LINE PLACEMENT PROCEDURE. DURING LINE PLACEMENT PROCEDURE PATIENT'S BLOOD PRESSURE CONTINUED TO INCREASE TO A MAX SYSTOLIC PRESSURE OF 190 DESPITE CLINICIAN'S ATTEMPT TO INCREASE THE EPINEPHRINE INFUSING ON CHANNEL B. FOLLOWING LINE PLACEMENT PROCEDURE IT WAS NOTED THAT THE VASOPRESSIN ON CHANNEL C WAS INFUSING INTO THE PATIENT AT 0.03 UNITS/MIN (9ML/HR). IT WAS REPORTED THAT THE VASOPRESSIN WAS UTILIZED EARLIER IN THE DAY HOWEVER THE LINE WAS STILL ATTACHED TO THE PATIENT AND THE INFUSION WAS INFUSING WITHOUT THE CLINICIAN STARTING IT. THE FOLLOWING DAY, IT WAS REPORTED THAT AT 1007 FENTANYL BOLUS 50MCG WAS GIVEN PRIOR TO SCHEDULED BRONCHOSCOPY . FOLLOWING BOLUS DOES, FENTANYL WAS PROGRAMMED TO INFUSE AT 25 MCG/HR = 2.5ML/HR AT 1008 . AT 1039 PATIENT WENT INTO CARDIAC ARREST, ACLS STARTED AT 1039. FENTANYL INFUSION WAS STOPPED. FENTANYL MEDICATION AND TUBING WAS SUBSEQUENTLY REMOVED FROM THE PUMP MODULE AT 1120. AT THAT TIME A NORMAL SALINE BOLUS WAS HUNG ON SAME PUMP MODULE PREVIOUSLY INFUSING FENTANYL. AT 1230 FOLLOWING NORMAL SALINE BOLUS, FENTANYL MEDIATION AND TUBING WAS PLACED BACK INTO PUMP MODULE AND PROGRAMMED TO RESUME INFUSING AT 25 MCG/HR = 2.5ML/HR. IT WAS NOTED HOWEVER AT 1330 THE FENTANYL INFUSION WAS ALARMING AIR IN LINE. CHAMBER AND BAG CHECKED AND NOTED TO BE EMPTY. PATIENT WAS ALREADY INTUBATED. VITAL SIGNS WERE MONITORED. THE NEXT DAY, THE PATIENT PASSED AWAY. ALTHOUGH ADDITIONAL ATTEMPTS WERE MADE FOR FURTHER INFORMATION, NO FURTHER INFORMATION WAS MADE AVAILABLE AND NO PRODUCTS WERE RETURNED TO BD FOR INVESTIGATION. PLEASE NOTE THAT THE OVER INFUSION OF NOREPINEPHRINE WAS REPORTED UNDER MFG REPORT # 2016493-2022-150982.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503365 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| D 8015| 8015