BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 15864476 · Received November 25, 2022

    Report

    Report Number
    2016493-2022-231527
    Event Type
    Malfunction
    Date Received
    November 25, 2022
    Date of Event
    September 19, 2022
    Report Date
    January 20, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801549
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    CORRECTION : IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2022-231527 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2022-231590, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 50ML INFUSION OF ZOSYN (2.25 GRAMS) WAS INTENDED TO INFUSE OVER 30 MINUTES, HOWEVER ENTIRE DOSE WAS INFUSED IN 10 MINUTES AND THE PUMP BEGAN ALARMING. WHEN THE PUMP WAS INSPECTED IT SHOWED A VOLUME TO BE INFUSED OF 34.7ML INSTEAD OF 50ML AND A REMAINING INFUSION TIME OF 20 MINUTES. THERE WAS NO HARM TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 50ML INFUSION OF ZOSYN (2.25 GRAMS) WAS INTENDED TO INFUSE OVER 30 MINUTES, HOWEVER ENTIRE DOSE WAS INFUSED IN 10 MINUTES AND THE PUMP BEGAN ALARMING. WHEN THE PUMP WAS INSPECTED IT SHOWED A VOLUME TO BE INFUSED OF 34.7ML INSTEAD OF 50ML AND A REMAINING INFUSION TIME OF 20 MINUTES. THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686864 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801549

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown