BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17772428 · Received September 19, 2023

    Report

    Report Number
    2016493-2023-230755
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 25, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 SECTION H6 OF 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. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B: B21. ANNEX C: C21. ANNEX D: D16. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, ANNEX A: A0404, A070903, A1801. ANNEX B: B01. ANNEX C: C070606, C17, C0201. ANNEX D: D07, D02. ANNEX G: G04061, G04052, G0405206, G0201204, G04055.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS OUT OF CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS OUT OF CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879996 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown