BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1112185 · Received August 6, 2008

    Report

    Report Number
    2016493-2008-00119
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 21, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNDERINFUSION OF AN UNKNOWN ANTIBIOTIC. USER DOES NOT RECALL THE VTBI, THE INTENDED RATE OR THE HEIGHT DIFFERENTIAL OF THE PRIMARY AND SECONDARY BAGS. THE USER STARTED AN ANTIBIOTIC TO INFUSE OVER 30 MINUTES. REPORTS AFTER 30 MINUTES, 20 ML REMAINED IN THE BAG AND THE LVP WAS REPROGRAMMED TO INFUSE THE REMAINDER OF THE MEDICATION. NO PATIENT HARM REPORTED, NO MEDICAL INTERVENTION REQUIRED AND NO ILL EFFECTS EXPERIENCED BY THE PATIENT. THE PCU AND LVP WERE REQUESTED AND SENT BUT NOT RECEIVED TO DATE. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    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 UNK ALARIS PC UNIT