BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 15309528 · Received August 29, 2022

    Report

    Report Number
    2016493-2022-183293
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    June 18, 2022
    Report Date
    December 7, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.

    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 2016493-2022-183293 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2022-183313, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PROGRAMMING ERROR THAT RESULTED IN MEDICATION INFUSING FASTER THAN EXPECTED. A 500ML BAG OF MEDICATION WAS INTENDED TO INFUSE OVER 24 HOURS AT A RATE OF 21ML/ HOUR. THE INFUSION WAS STARTED AT APPROXIMATELY 2216. HOWEVER, THE FOLLOW DAY AT APPROXIMATELY 0700, THE BAG WAS FOUND TO CONTAIN LESS THAN 100ML OF FLUID. THE PHARMACIST INDICATED THAT THERE WAS CONCERN THAT THE INFUSION WAS PROGRAMMED AT A HIGH RATE THAN ORDERED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A PROGRAMMING ERROR THAT RESULTED IN MEDICATION INFUSING FASTER THAN EXPECTED. A 500ML BAG OF MEDICATION WAS INTENDED TO INFUSE OVER 24 HOURS AT A RATE OF 21ML/ HOUR. THE INFUSION WAS STARTED AT APPROXIMATELY 2216. HOWEVER, THE FOLLOW DAY AT APPROXIMATELY 0700, THE BAG WAS FOUND TO CONTAIN LESS THAN 100ML OF FLUID. THE PHARMACIST INDICATED THAT THERE WAS CONCERN THAT THE INFUSION WAS PROGRAMMED AT A HIGH RATE THAN ORDERED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317804 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown