BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12567201 · Received October 4, 2021

    Report

    Report Number
    2016493-2021-63192
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 28, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2719-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A,G,B,C AND D GRIDS, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #. OMIT: A090103 - NO AUDIBLE PROMPT / FEEDBACK (2282), G0600101 - ALARM, AUDIBLE, B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION, D16 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FAILED TO ALARM. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    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 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 · 1

    IT WAS REPORTED THAT THE DEVICE HAD FAILED TO ALARM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468430 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown