BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12630902 · Received October 14, 2021

    Report

    Report Number
    2016493-2021-64948
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 24, 2021
    Report Date
    October 19, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: A140504 - INACCURATE DELIVERY (2339).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN INFUSION ERROR WHEREIN THE CLINICIAN CHOSE THE INCORRECT HEPARIN CONCENTRATION. THE INFORMATION ON PATIENT INVOLVEMENT IS NOT KNOWN.

    Additional Manufacturer Narrative · 1

    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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFUSION ERROR WHEREIN THE CLINICIAN CHOSE THE INCORRECT HEPARIN CONCENTRATION. THE INFORMATION ON PATIENT INVOLVEMENT IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534516 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1