BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17196705 · Received June 26, 2023

    Report

    Report Number
    2016493-2023-186509
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 1, 2023
    Report Date
    August 16, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1768-2019
    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

    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?, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #, ANNEX A: A040101, A0801 ANNEX G: G04100, G04090 ANNEX B: B01. ANNEX C: C07. ANNEX D: D15, D02.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FAILED RATE ACCURACY AND CALIBRATION TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FAILED RATE ACCURACY AND CALIBRATION TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452683 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown