BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16349965 · Received February 10, 2023

    Report

    Report Number
    2016493-2023-113471
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 20, 2023
    Report Date
    March 31, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH NPS SURVEY THAT DEVICES APPEAR TO BE CONFUSING TO NURSING STAFF. UPON FURTHER CUSTOMER FOLLOW UP IT WAS NOTED THAT THIS GENERAL STATEMENT WAS MADE AS A RESULT OF LOOKING AT THE NUMBER OF GUARDRAIL OVERRIDES. THE CUSTOMER SUSPECTS THAT "NURSES SOMETIMES CHOOSE THE WRONG PROTOCOL FOR SOMETHING LIKE HEPARIN". CUSTOMER FEELS IT IS MORE EDUCATION RELATED RATHER THAN A PUMP ISSUE ITSELF. CUSTOMER DID NOT PROVIDE SPECIFIC EXAMPLES. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH NPS SURVEY THAT DEVICES APPEAR TO BE CONFUSING TO NURSING STAFF. UPON FURTHER CUSTOMER FOLLOW UP IT WAS NOTED THAT THIS GENERAL STATEMENT WAS MADE AS A RESULT OF LOOKING AT THE NUMBER OF GUARDRAIL OVERRIDES. THE CUSTOMER SUSPECTS THAT "NURSES SOMETIMES CHOOSE THE WRONG PROTOCOL FOR SOMETHING LIKE HEPARIN". CUSTOMER FEELS IT IS MORE EDUCATION RELATED RATHER THAN A PUMP ISSUE ITSELF. CUSTOMER DID NOT PROVIDE SPECIFIC EXAMPLES. THERE WAS NO INFORMATION ON PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162422 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown