BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12873894 · Received November 25, 2021

    Report

    Report Number
    2016493-2021-72499
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Date of Event
    April 1, 2021
    Report Date
    February 2, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT: A140504 - INACCURATE DELIVERY (2339).

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ALARIS SYSTEM SYRINGE MODULES AN INITIAL MINI BOLUS THAT GOES TO THE PATIENT THAT IS NOT ACCOUNTED FOR EACH TIME OF INFUSION STARTS OFF. AFTER CHANGING THE SYRINGE, THIS DOES NOT HAPPENED WHEN THE INFUSION IS INITIATED WITH THE FIRST SYRINGE. IT STATES THAT THE ISSUE IS HAPPENING FOR MONTHS THROUGH DIFFERENT DEPARTMENTS, BUT CUSTOMER COULD NOT GIVE THE EXACT DATES AND OCCURRENCE SINCE THEY DOES NOT RECALL AT THE POINT OF TIME AND THERE IS NO SPECIFIC PUMPS. THERE WAS PATIENT INVOLVEMENT. TASK 3972994 COMPLETED: ACCORDING TO THE CUSTOMER THE REPORTED SYMPTOMS WILL OCCUR FOR THE FIRST FEW SECONDS AND QUICKLY NORMALIZE WITHOUT ANY INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ALARIS SYSTEM SYRINGE MODULES AN INITIAL MINI BOLUS THAT GOES TO THE PATIENT THAT IS NOT ACCOUNTED FOR EACH TIME OF INFUSION STARTS OFF. AFTER CHANGING THE SYRINGE, THIS DOES NOT HAPPENED WHEN THE INFUSION IS INITIATED WITH THE FIRST SYRINGE. IT STATES THAT THE ISSUE IS HAPPENING FOR MONTHS THROUGH DIFFERENT DEPARTMENTS, BUT CUSTOMER COULD NOT GIVE THE EXACT DATES AND OCCURRENCE SINCE THEY DOES NOT RECALL AT THE POINT OF TIME AND THERE IS NO SPECIFIC PUMPS. THERE WAS PATIENT INVOLVEMENT. TASK 3972994 COMPLETED: ACCORDING TO THE CUSTOMER THE REPORTED SYMPTOMS WILL OCCUR FOR THE FIRST FEW SECONDS AND QUICKLY NORMALIZE WITHOUT ANY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770979 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015