BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 13889600 · Received March 24, 2022

    Report

    Report Number
    2016493-2022-118170
    Event Type
    Death
    Date Received
    March 24, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 30, 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
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF DEATH IS UNKNOWN. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2022-118170 IS A CONCOMITANT. THE DEVICE WAS AFFECTED DUE TO THE ISSUE OBSERVED ON THE SUSPECT DEVICE CAPTURED IN MANUFACTURER REPORT NUMBER 2016493-2022-118169. NOT APPLICABLE. DEVICE EVALUATED BY BD SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PUMP MODULE AND SYRINGE MODULE (CHANNELS A AND B) SPONTANEOUSLY ALARMED ¿CHANNEL DISCONNECTED¿ AND STOPPED INFUSING. IT ALSO WAS NOTED THAT THE PCU "POWERED OFF" WHILE RUNNING. THIS REPORTEDLY OCCURRED DURING A PATIENT "CODE" EVENT, ONE MODULE WAS INFUSING EPINEPHRINE AND THE OTHER WAS AN INTERMITTENT MEDICATION LINE. THE PATIENT EXPIRED FOLLOWING THE CODE. THE CLINICIAN INDICATED THE SAME PUMP ISSUE HAD ALSO OCCURRED EARLIER IN THE SHIFT, BUT DID NOT PROVIDE ADDITIONAL DETAILS. THE CLINICIAN FURTHER STATED THAT THEY DO NOT BELIEVE THAT THE PUMP ISSUE WAS A CONTRIBUTING FACTOR IN PATIENT'S DEATH, AS THE PATIENT WAS GETTING DOSES OF EPINEPHRINE IV PUSH THROUGHOUT THE CODE. HOWEVER, THE CUSTOMER FURTHER STATED THAT THEY WERE UNABLE TO DEFINITIVELY KNOW, AND CLASSIFIED IT AS "UNABLE TO DETERMINE." ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED. DEATH WAS NOT CONTRIBUTED TO THE BD DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PUMP MODULE AND SYRINGE MODULE (CHANNELS A AND B) SPONTANEOUSLY ALARMED ¿CHANNEL DISCONNECTED¿ AND STOPPED INFUSING. IT ALSO WAS NOTED THAT THE PCU "POWERED OFF" WHILE RUNNING. THIS REPORTEDLY OCCURRED DURING A PATIENT "CODE" EVENT, ONE MODULE WAS INFUSING EPINEPHRINE AND THE OTHER WAS AN INTERMITTENT MEDICATION LINE. THE PATIENT EXPIRED FOLLOWING THE CODE. THE CLINICIAN INDICATED THE SAME PUMP ISSUE HAD ALSO OCCURRED EARLIER IN THE SHIFT, BUT DID NOT PROVIDE ADDITIONAL DETAILS. THE CLINICIAN FURTHER STATED THAT THEY DO NOT BELIEVE THAT THE PUMP ISSUE WAS A CONTRIBUTING FACTOR IN PATIENT'S DEATH, AS THE PATIENT WAS GETTING DOSES OF EPINEPHRINE IV PUSH THROUGHOUT THE CODE. HOWEVER, THE CUSTOMER FURTHER STATED THAT THEY WERE UNABLE TO DEFINITIVELY KNOW, AND CLASSIFIED IT AS "UNABLE TO DETERMINE." ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED. DEATH WAS NOT CONTRIBUTED TO THE BD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927850 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Death