BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 15299766 · Received August 26, 2022

    Report

    Report Number
    2016493-2022-183175
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    August 17, 2022
    Report Date
    August 18, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 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 THAT THE 8100 HAD AN ERROR CODE 14-901-1775 AND ERROR LOG 210.5020 , AFTER REPLACING A DISPLAY BOARD AND EVEN RE-FLASHING THE MODULE STILL SHOWING THE SAME ERROR 14-901-1775. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436114 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown