BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16333703 · Received February 9, 2023

    Report

    Report Number
    2016493-2023-109420
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 18, 2023
    Report Date
    March 7, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMDRF ANNEX A AND G CODES.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED ON NPS SURVEY THAT THE CUSTOMER REPORTS DEVICES WOULD SHUT DOWN OFTEN. THERE WAS PATIENT INVOLVEMENT BUT THE INFORMATION ON PATIENT IMPACT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED ON NPS SURVEY THAT THE CUSTOMER REPORTS DEVICES WOULD SHUT DOWN OFTEN. THERE WAS PATIENT INVOLVEMENT BUT THE INFORMATION ON PATIENT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462082 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015