BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14012816 · Received April 5, 2022

    Report

    Report Number
    2016493-2022-125885
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    March 14, 2022
    Report Date
    May 13, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMDRF ANNEX A, G ,D GRIDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ALARM - ERROR CODES / MESSAGES. THE LOGIC BOARD CAUSING ERRORS 133.6090 AND 133.6080. I/O BOARDS ERRORS CONTINUED STAYED WITH PCU. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ALARM - ERROR CODES / MESSAGES. THE LOGIC BOARD CAUSING ERRORS 133.6090 AND 133.6080. I/O BOARDS ERRORS CONTINUED STAYED WITH PCU. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94716 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown