BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 15841285 · Received November 22, 2022

    Report

    Report Number
    2016493-2022-228330
    Event Type
    Death
    Date Received
    November 22, 2022
    Date of Event
    October 28, 2022
    Report Date
    February 8, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. 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

    OMIT: B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE. CORRECTION: RETURNED TO MANUFACTURER ON. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY, IMDRF ANNEX A, G, B, C AND 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. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, ADMITTED TO THE HOSPITAL DUE TO SEVERE TRAUMATIC BRAIN INJURY AFTER A GUNSHOT WOUND (GSW) TO THE HEAD AND ALREADY PRONOUNCED ¿BRAIN DEAD,¿ WAS A ¿LIFE CONNECTION CASE¿ (ORGAN DONATION) AND ON A NOREPINEPHRINE DRIP FOR CADAVERIC DONOR CARE. WHEN A NEW BAG OR NOREPINEPHRINE WAS SCANNED, THE PUMP HAD TO BE MANUALLY PROGRAMMED FOR THE DRIP. THE CLINICIAN ACCEPTED THE MEDICATION ADMINISTRATION ON THE MEDICATION ADMINISTRATION RECORD (MAR) AND DIRECTED THE ATTENTION TO THE PUMP. HOWEVER, THE PCU BEGAN ALARMING AND DISPLAYED ERROR CODE 800.8000 WITH A MESSAGE THAT THE DEVICE MUST BE TURNED OFF AND THE INFUSION PROGRAMING WERE NOT RESTORABLE. THE DEVICE WAS TURNED OFF, AND THEN TURNED BACK ON. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED EXTREMELY LOW (MEAN ARTERIAL PRESSURE OF 26, THE GOAL WAS GREATER THAN 60), DURING THE TIME NOREPINEPHRINE DRIP WAS PAUSED FOR 60 TO 90 SECONDS. ALL PUMPS HAD TO BE RESCANNED AND PATIENT'S BLOOD PRESSURE EVENTUALLY RECOVERED SLOWLY. THE WHOLE EVENT FROM THE TIME OF PUMP FAILURE TO IMPROVEMENT IN BLOOD PRESSURE WAS FIVE MINUTES, AND IT TOOK FORTY (40) MINUTES FOR THE BLOOD PRESSURE TO IMPROVE. THE CHANNELS WERE WORKING FINE AFTER THE EVENT. THE HOSPITAL¿S CLINICIAN (CLINICAL TECHNOLOGY INTEGRATION/SIMULATION MANAGER) REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTED TO DEATH AS THE PATIENT WAS ALREADY PRONOUNCED BRAIN DEAD PRIOR TO THE DEVICE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, ADMITTED TO THE HOSPITAL DUE TO SEVERE TRAUMATIC BRAIN INJURY AFTER A GUNSHOT WOUND (GSW) TO THE HEAD AND ALREADY PRONOUNCED ¿BRAIN DEAD,¿ WAS A ¿LIFE CONNECTION CASE¿ (ORGAN DONATION) AND ON A NOREPINEPHRINE DRIP FOR CADAVERIC DONOR CARE. WHEN A NEW BAG OR NOREPINEPHRINE WAS SCANNED, THE PUMP HAD TO BE MANUALLY PROGRAMMED FOR THE DRIP. THE CLINICIAN ACCEPTED THE MEDICATION ADMINISTRATION ON THE MEDICATION ADMINISTRATION RECORD (MAR) AND DIRECTED THE ATTENTION TO THE PUMP. HOWEVER, THE PCU BEGAN ALARMING AND DISPLAYED ERROR CODE 800.8000 WITH A MESSAGE THAT THE DEVICE MUST BE TURNED OFF AND THE INFUSION PROGRAMING WERE NOT RESTORABLE. THE DEVICE WAS TURNED OFF, AND THEN TURNED BACK ON. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED EXTREMELY LOW (MEAN ARTERIAL PRESSURE OF 26, THE GOAL WAS GREATER THAN 60), DURING THE TIME NOREPINEPHRINE DRIP WAS PAUSED FOR 60 TO 90 SECONDS. ALL PUMPS HAD TO BE RESCANNED AND PATIENT'S BLOOD PRESSURE EVENTUALLY RECOVERED SLOWLY. THE WHOLE EVENT FROM THE TIME OF PUMP FAILURE TO IMPROVEMENT IN BLOOD PRESSURE WAS FIVE MINUTES, AND IT TOOK FORTY (40) MINUTES FOR THE BLOOD PRESSURE TO IMPROVE. THE CHANNELS WERE WORKING FINE AFTER THE EVENT. THE HOSPITAL¿S CLINICIAN (CLINICAL TECHNOLOGY INTEGRATION/SIMULATION MANAGER) REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTED TO DEATH AS THE PATIENT WAS ALREADY PRONOUNCED BRAIN DEAD PRIOR TO THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707183 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Death 8100(3)| 8110