BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17142575 · Received June 16, 2023

    Report

    Report Number
    2016493-2023-182444
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 23, 2023
    Report Date
    September 1, 2023
    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

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-182444 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-182419, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    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. H3 : NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALARMED FOR "SYSTEM ERROR- OPERATING CHANNELS WILL CONTINUE AS PROGRAMMED. REPLACE PROGRAMMING MODULE WITH AN OPERATIONAL UNIT AS SOON AS POSSIBLE. SETTINGS UN RESTORABLE." WHILE TRANSPORTING A PATIENT. ERROR CODE 13-1201-1006. PATIENT WAS TRANSFERRED TO ANOTHER PUMP. UPON CUSTOMER BIOMED INTERNAL REVIEW OF THE LOGS 800.8000 WAS NOTED. IT WAS ALSO NOTED THAT ONE OF THE PUMP MODULES REQUIRED A NEW BOTTLE SIDE PRESSURE SENSOR. THERE WAS PATIENT INVOLVEMENT HOWEVER NO PATIENT HARM. A REPORT WAS RECEIVED FROM HEALTH CANADA'S CANADA VIGILANCE PROGRAM WHICH STATES, "ISSUE WAS WITH THE ALARIS PCU BRAIN 8015 MODEL (S/N 14317285) - SYSTEM ERROR OCCURRED 800.8000.0 ERROR CODE WHICH IS AN AN OPERATING SYSTEM FAILURE. DURING SYSTEM ERROR, CHANNEL CONTINUE TO INFUSE; HOWEVER, USERS UNABLE TO CHANGE PROGRAMMING OR INTERACT WITH PUMP IN ANY WAY. - FIX IS TO FLASH THE PCU; HOWEVER, BIOMED REFRAINED FROM REPAIRING AS SENDING TO VENDOR BD FOR INVESTIGATING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE ALARMED FOR "SYSTEM ERROR- OPERATING CHANNELS WILL CONTINUE AS PROGRAMMED. REPLACE PROGRAMMING MODULE WITH AN OPERATIONAL UNIT AS SOON AS POSSIBLE. SETTINGS UN RESTORABLE." WHILE TRANSPORTING A PATIENT. ERROR CODE 13-1201-1006. PATIENT WAS TRANSFERRED TO ANOTHER PUMP. UPON CUSTOMER BIOMED INTERNAL REVIEW OF THE LOGS 800.8000 WAS NOTED. IT WAS ALSO NOTED THAT ONE OF THE PUMP MODULES REQUIRED A NEW BOTTLE SIDE PRESSURE SENSOR. THERE WAS PATIENT INVOLVEMENT HOWEVER NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434540 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8100(2)