BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17123043 · Received June 14, 2023

    Report

    Report Number
    2016493-2023-180703
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 11, 2023
    Report Date
    June 16, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-180703 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-180728, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    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. H3: DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP MODULES HAD CHANNEL ERROR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. THIRD PARTY TESTING WAS UNABLE TO DUPLICATE THE ERROR. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION WAS KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP MODULES HAD CHANNEL ERROR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. THIRD PARTY TESTING WAS UNABLE TO DUPLICATE THE ERROR. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION WAS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956334 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown