BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 14600160 · Received June 6, 2022

    Report

    Report Number
    2016493-2022-150982
    Event Type
    Death
    Date Received
    June 6, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 20, 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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF DEATH IS UNKNOWN. 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 THIS MDR REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: DATE OF EVENT, DATE OF DEATH, CONCOMITANT MED PROD DATA. ADDITIONAL INFORMATION: EVENT ATTRIBUTED TO, DESCRIBE EVENT OR PROBLEM, TYPE OF REPORTABLE EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICIAN TURNED PROPOFOL INFUSION OFF. WHEN THE PATIENT'S BLOOD PRESSURE BECAME UNSTEADY, THE CLINICIAN WENT TO TURN THE PROPOFOL BACK ON, HOWEVER WHEN CLINICIAN BUMPED INTO THE PUMP IT TURNED ON BY ITSELF. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE, NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT HOWEVER PATIENT HARM IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE SETTING UP THE PATIENT ROOM 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 INFUSION FROM CHANNEL D TO CHANNEL A AND REPROGRAMMED INFUSION TO RUN AT 30MCG/KG/MIN TO ALLOW FOR INCREASE SEDATION DURING CENTRAL LINE PLACEMENT PROCEDURE. DURING LINE PLACEMENT PROCEDURE PATIENT BLOOD PRESSURE CONTINUED TO INCREASE TO A MAX SYSTOLIC PRESSURE OF 190 DESPITE CLINICIAN 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 PATIENT WAS ALREADY INTUBATED. THE FOLLOWING DAY, THE PATIENT PASSED AWAY, HOWEVER CONFIRMED BY CUSTOMER NOT AS A RESULT OF THE VASOPRESSIN OVER INFUSION. ALTHOUGH ADDITIONAL ATTEMPTS WERE MADE FOR INFORMATION, NO FURTHER INFORMATION OR PRODUCTS WERE SENT TO BD FOR INVESTIGATION. DEATH WAS NOT CONTRIBUTED TO THE BD DEVICE.

    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 FENTANYL WAS REPORTED UNDER MFG REPORT # 2016493-2022-148695.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197073 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death| R 8015| 8015