BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS SYSTEM

    MDR report key: 16805154 · Received April 25, 2023

    Report

    Report Number
    2016493-2023-153594
    Event Type
    Death
    Date Received
    April 25, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 16, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION : IMDRF ANNEX A.

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF DEATH IS UNKNOWN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A THIRD-PARTY ORGANIZATION (VIZIENT) THAT THEY RECEIVED AN INFORMATION WHERE AN INFUSION PUMP "MALFUNCTION" AND "A CARDIAC PATIENT DIED A FEW WEEKS AGO." NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER HAS NOT RESPONDED TO THE MULTIPLE DUE DILIGENCE ATTEMPTS BY THE MANUFACTURER TO OBTAIN ADDITIONAL INFORMATION OR CLARIFICATION. ALSO, THE MANUFACTURER SPOKE WITH THE HOSPITAL DIRECTOR OF CLINICAL ENGINEERING, AND THEY INDICATED THERE WAS UNAWARE OF ANY PATIENT DEATH AS A RESULT OF AN INFUSION PUMP MALFUNCTION WITHIN THE TIMEFRAME ALLEGED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A THIRD-PARTY ORGANIZATION (VIZIENT) THAT THEY RECEIVED AN INFORMATION WHERE AN INFUSION PUMP "MALFUNCTION" AND "A CARDIAC PATIENT DIED A FEW WEEKS AGO." NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER HAS NOT RESPONDED TO THE MULTIPLE DUE DILIGENCE ATTEMPTS BY THE MANUFACTURER TO OBTAIN ADDITIONAL INFORMATION OR CLARIFICATION. ALSO, THE MANUFACTURER SPOKE WITH THE HOSPITAL DIRECTOR OF CLINICAL ENGINEERING, AND THEY INDICATED THERE WAS UNAWARE OF ANY PATIENT DEATH AS A RESULT OF AN INFUSION PUMP MALFUNCTION WITHIN THE TIMEFRAME ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080558 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death 8015.