BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 15535593 · Received October 4, 2022

    Report

    Report Number
    2016493-2022-202353
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 6, 2022
    Report Date
    November 23, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED. 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. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Additional Manufacturer Narrative · 0

    CORRECTION : IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2022-202353 IS A CONCOMITANT. THE DEVICE WAS AFFECTED DUE TO THE ISSUE OBSERVED ON THE SUSPECT DEVICE CAPTURED IN MANUFACTURER REPORT NUMBER 2016493-2022-206208.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHEMOTHERAPY INFUSION, PUMP MODULES AND SYRINGE MODULE EXPERIENCED A COMMUNICATION ERROR AND TURNED OFF. WHEN DEVICE WAS REBOOTED, NO PREVIOUS INFUSION DATA WAS RESTORED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CHEMOTHERAPY INFUSION, PUMP MODULES AND SYRINGE MODULE EXPERIENCED A "COMMUNICATION ERROR" AND TURNED OFF. WHEN DEVICE WAS REBOOTED, NO PREVIOUS INFUSION DATA WAS RESTORED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. PER CUSTOMER'S INTERNAL INVESTIGATION, IT WAS FOUND THAT THE "PCU RECEIVED ERROR CODE 800.8000.0 MULTIPLE TIMES DURING THE TIME OF THE INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2934163 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown