BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12588848 · Received October 7, 2021

    Report

    Report Number
    2016493-2021-63835
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 5, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE KEPT SHOWING "CALIBRATION REQUIRED" EVEN CALIBRATION WAS ALREADY COMPLETED. (B)(6) CONFIRMED CALIBRATION WAS COMPLETED AND FOLLOWED BY PREVENTIVE MAINTENANCE ON THE SYRINGE. BUT THE PROBLEM STILL EXIST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490537 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1