BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 1810635 · Received August 3, 2010

    Report

    Report Number
    2016493-2010-00458
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 19, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. THE CUSTOMER'S REPORT OF AN ERRONEOUS VALUE DISPLAYED FOR THE TOTAL BOLUS DOSE WAS CONFIRMED. FURTHER TESTING SHOWED THAT DESPITE THE ERRONEOUS TOTAL DOSE BEING DISPLAYED, THE CORRECT VOLUME WAS DELIVERED. THE CAUSE OF THE REPORTED ISSUE HAS BEEN ISOLATED TO AN ANOMALY ASSOCIATED TO THE DEVICE'S PROCESSOR IN PERFORMING CERTAIN SO-CALLED FLOATING POINT OPERATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING A WEIGHT BASED DRUG BOLUS DOSE PROGRAMMING, THE NURSE NOTICED THAT THE DEVICE DISPLAYED THE TOTAL DOSE ERRONEOUSLY. IT WAS FURTHER DISCOVERED THAT ALTHOUGH THE TOTAL DOSE DISPLAY WAS INCORRECT, THE ACTUAL VOLUME TO BE DELIVERED WAS CORRECT AND ACCURATE FOR THE EXPECTED DOSE. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PC UNIT FRN CAREFUSION CORP. 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO ALARIS PUMP MODULE SERIAL # UNK