BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16596018 · Received March 23, 2023

    Report

    Report Number
    2016493-2023-132773
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 28, 2023
    Report Date
    June 12, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO REMOVE THE MFR REPORT # 2016493-2023-132773. AFTER FURTHER REVIEW, IT WAS DETERMINED THE REPORT IS A DUPLICATE OF THE PREVIOUSLY REPORTED EVENT CAPTURED UNDER MFR REPORT # 2016493-2023-140583.

    Additional Manufacturer Narrative · 0

    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. PER 803.52(F)(11)(III), THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[BATTERY REPLACED WITHIN THE LAST 6 MONTHS. DURING RECONDITIONING UNIT ALARMS. ERROR LOG SHOWED CODE: 800.8000- SOFTWARE FAILURE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[BATTERY REPLACED WITHIN THE LAST 6 MONTHS. DURING RECONDITIONING UNIT ALARMS. ERROR LOG SHOWED CODE: 800.8000- SOFTWARE FAILURE.]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479898 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown