BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18745541 · Received February 21, 2024

    Report

    Report Number
    2016493-2024-15055
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 17, 2024
    Report Date
    March 27, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    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

    OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. ADDITIONAL INFORMATION : DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY, IMDRF ANNEX A, B, C, D, G CODES AND MANUFACTURER NARRATIVE. 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 SECTION H6 OF THIS MDR REPORT. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OVER INFUSION OF HPN WHILE USING A SYRINGE PUMP. THE INFUSION WAS COMPLETED ONE SOONER THAN EXPECTED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OVER INFUSION OF HPN WHILE USING A SYRINGE PUMP. THE INFUSION WAS COMPLETED ONE SOONER THAN EXPECTED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460101 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015