BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12947589 · Received December 7, 2021

    Report

    Report Number
    2016493-2021-75419
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 13, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: A140504 INACCURATE DELIVERY (2339). 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

    IN A NPS SURVEY RECEIVED, IT WAS REPORTED THAT THE CUSTOMER HAS SEEN ERRORS WHERE THE RIGHT MEDICINE WAS PROGRAMMED INTO THE PUMP, BUT THE WRONG MEDICATION WAS DELIVERED. THERE WAS PATIENT INVOLVEMENT BUT IMPACT WAS UNKNOWN.

    Description of Event or Problem · 0

    IN A NPS SURVEY RECEIVED, IT WAS REPORTED THAT THE CUSTOMER HAS SEEN ERRORS WHERE THE RIGHT MEDICINE WAS PROGRAMMED INTO THE PUMP, BUT THE WRONG MEDICATION WAS DELIVERED. THERE WAS PATIENT INVOLVEMENT BUT IMPACT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852369 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown