BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17675156 · Received September 4, 2023

    Report

    Report Number
    2016493-2023-222924
    Event Type
    Malfunction
    Date Received
    September 4, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 28, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER2016493-2023-222924 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-222927, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. 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 THAT THE STUDY DRUG WAS STARTED AT THE RATE OF 283 ML/HR. WHEN THE PUMP WAS BEEPING FOR COMPLETION OF INFUSION, IT APPEARED TO STILL BE NEARLY FULL. THE PUMP MODULE STATED THAT THE VOLUME TO BE INFUSED WAS 114ML, WHICH HAS BEEN PROGRAMMED FOR 115 ML TO ALLOW 25ML FOR FLUSH, FOR A TOTAL VOLUME OF INFUSION OF 140ML. THE PATIENT LINE WAS FLUSHED WITH "D5W" WITHOUT DIFFICULTY, AND THE PUMP MODULE WAS CHANGED AND THE PATIENT COMPLETED THE INFUSION IN 30 MIN FROM THAT TIME WITHOUT DIFFICULTY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STUDY DRUG WAS STARTED AT THE RATE OF 283 ML/HR. WHEN THE PUMP WAS BEEPING FOR COMPLETION OF INFUSION, IT APPEARED TO STILL BE NEARLY FULL. THE PUMP MODULE STATED THAT THE VOLUME TO BE INFUSED WAS 114ML, WHICH HAS BEEN PROGRAMMED FOR 115 ML TO ALLOW 25ML FOR FLUSH, FOR A TOTAL VOLUME OF INFUSION OF 140ML. THE PATIENT LINE WAS FLUSHED WITH "D5W" WITHOUT DIFFICULTY, AND THE PUMP MODULE WAS CHANGED AND THE PATIENT COMPLETED THE INFUSION IN 30 MIN FROM THAT TIME WITHOUT DIFFICULTY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287881 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015