BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12293754 · Received August 9, 2021

    Report

    Report Number
    2016493-2021-57363
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 20, 2021
    Report Date
    September 3, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: A140502 - FREE OR UNRESTRICTED FLOW (2945) THE REPORTED ISSUE THAT THE DEVICE CONTINUED TO INFUSION EVEN AFTER THE DEVICE PROMPTED "INFUSION COMPLETE" WAS CONFIRMED BY TECH SUPPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE CONTINUED TO INFUSION EVEN AFTER THE DEVICE PROMPTED "INFUSION COMPLETE". THE PATIENT WAS BEING GIVEN PROPOFOL AND EVENTUALLY THE ENTIRE BAG EMPTIED. THERE WAS PATIENT INVOLVEMENT BUT THE INFORMATION ON PATIENT IMPACT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DATE OF EVENT IS UNKNOWN. BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 CONTINUED TO INFUSION EVEN AFTER THE DEVICE PROMPTED "INFUSION COMPLETE". THE PATIENT WAS BEING GIVEN PROPOFOL AND EVENTUALLY THE ENTIRE BAG EMPTIED. THERE WAS PATIENT INVOLVEMENT BUT THE INFORMATION ON PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191027 ALARIS SYSTEM INFUSION PUMP FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 8015| 8015