BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 12292886 · Received August 9, 2021

    Report

    Report Number
    2016493-2021-57280
    Event Type
    Death
    Date Received
    August 9, 2021
    Date of Event
    July 19, 2021
    Report Date
    May 20, 2022
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE ROOT CAUSE FOR THE REPORTED ISSUE OF A PUMP ISSUE & FAILURE TO INFUSE MEDICATION WAS NOT DETERMINED. THE REPORTED ISSUE THAT THERE WAS A PUMP ISSUE & FAILURE TO INFUSE MEDICATION COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME, AND PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 0

    A REPORT WAS RETRIEVED FROM HEALTH (B)(4) MEDICAL DEVICE INCIDENTS DATABASE REGARDING ISSUES INVOLVING, DEATH, INTRACRANIAL HEMORRHAGE, FAILURE TO INFUSE.

    Description of Event or Problem · 0

    A REPORT WAS RETRIEVED FROM HEALTH CANADA MEDICAL DEVICE INCIDENTS DATABASE REGARDING ISSUES INVOLVING, DEATH, INTRACRANIAL HEMORRHAGE, FAILURE TO INFUSE. DEATH WAS NOT CONTRIBUTED TO THE BD DEVICE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RETRIEVED FROM HEALTH CANADA MEDICAL DEVICE INCIDENTS DATABASE REGARDING ISSUES INVOLVING, DEATH, INTRACRANIAL HEMORRHAGE, FAILURE TO INFUSE. DEATH WAS NOT CONTRIBUTED TO THE BD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190912 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death