BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1242536 · Received November 20, 2008

    Report

    Report Number
    2016493-2008-00170
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 20, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED, AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INCIDENT INVOLVING A PATIENT THAT WAS GIVEN THE WRONG DOSAGE ON AN ALARIS PUMP, THEY HAD DOWNLOADED EVENT LOG AND REQUESTED INTERPRETATION FOR THEIR STAFF TO REVIEW. THE PATIENT HAD A MAINTENANCE FLUID, NO PROGRAMMED IN GUARDRAILS. DEVICE WAS NOTED TO BE RUNNING AT 75 ML BUT SHOULD HAVE BEEN AT 15 ML/HR. NURSE STATED THAT SHE DID NOT CHANGE THE DOSE. CUSTOMER WAS NOT SURE WHETHER THE PARENT CHANGED THE DOSE OR NOT BECAUSE THE NURSE SAID SHE CHECKED THE DOSE IN THE MORNING, AND IT WAS CORRECT, AND THEN AT 1230, THE PHYSICIAN NOTICED THE WRONG DOSE INFUSING. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS NOT HARMED. DEVICE LOG HAS BEEN RECEIVED; INVESTIGATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ALARIS PC UNIT