BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 14741967 · Received June 20, 2022

    Report

    Report Number
    2016493-2022-155070
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 27, 2022
    Report Date
    July 21, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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

    CORRECTION: ANNEX B: B21, ANNEX C: C21 AND ANNEX D: D16. ADDITIONAL INFORMATION: ANNEX A: A070908, ANNEX B: B01, ANNEX C: C07, ANNEX D: D02 AND ANNEX G: G03005. DEVICE AVAILABLE FOR EVAL? RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUFACTURER?, DEVICE EVAL BY MANUFACTURER?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 242.4030/AIL JUST REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 242.4030/AIL JUST REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794723 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown