BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17037476 · Received June 1, 2023

    Report

    Report Number
    2016493-2023-172480
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 4, 2023
    Report Date
    July 4, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2023-172480 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2023-175840, 2016493-2023-175838, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    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. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE HAD A PROGRAMMING ERROR. ALLEGEDLY, THE CLINICIAN NEEDED TO ADD A CHANNEL TO THE PUMP SET UP. WHEN THEY ADDED THE CHANNEL REPORTEDLY THE "ENTIRE PUMP WENT OFF". NO ERROR MESSAGES WERE NOTED. WHEN THE CLINICIAN TURNED THE DEVICE BACK ON, THEY HIT THE RESTORE BUTTON. IT WAS REPORTED THE RESTORE FUNCTION ALLEGEDLY BROUGHT UP DEXAMETHASONE RATHER THAN THE ALREADY PREVIOUSLY ORDERED INFUSION OF DEXMEDETOMIDINE. IT WAS REPORTED THAT THE CLINICIAN UNKNOWINGLY STARTED THE INCORRECT CONCENTRATION OF MEDICATION. AS A RESULT, THE PATIENT RECEIVED AN INAPPROPRIATE BOLUS DOSE OF DEXMEDETOMIDINE. PATIENT REQUIRED CONTINUED MONITORING AND AN ELECTROCARDIOGRAPH (EKG) TEST. THERE WAS NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE HAD A PROGRAMMING ERROR. ALLEGEDLY, THE CLINICIAN NEEDED TO ADD A CHANNEL TO THE PUMP SET UP. WHEN THEY ADDED THE CHANNEL REPORTEDLY THE "ENTIRE PUMP WENT OFF". NO ERROR MESSAGES WERE NOTED. WHEN THE CLINICIAN TURNED THE DEVICE BACK ON, THEY HIT THE RESTORE BUTTON. IT WAS REPORTED THE RESTORE FUNCTION ALLEGEDLY BROUGHT UP DEXAMETHASONE RATHER THAN THE ALREADY PREVIOUSLY ORDERED INFUSION OF DEXMEDETOMIDINE. THE CLINICIAN UNKNOWINGLY STARTED THE INCORRECT CONCENTRATION OF MEDICATION. AS A RESULT, THE PATIENT RECEIVED AN INAPPROPRIATE BOLUS DOSE OF DEXMEDETOMIDINE. PATIENT REQUIRED CONTINUED MONITORING AND AN ELECTROCARDIOGRAPH (EKG) TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132251 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown