BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12237645 · Received July 28, 2021

    Report

    Report Number
    2016493-2021-56334
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    July 8, 2021
    Report Date
    May 18, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B : B17. ANNEX C : C20. ANNEX D : D15 . ADDITIONAL INFORMATION: ANNEX A : A090202. ANNEX G : G05005. ANNEX B : B01. ANNEX C : C16. ANNEX D : C16.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD FAINT/DIM LED'S ON DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF EVENT IS UNKNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD FAINT/DIM LED'S ON DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133691 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown