BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS INFUSION SYSTEM

    MDR report key: 1343071 · Received March 11, 2009

    Report

    Report Number
    2016493-2009-00022
    Event Type
    Other
    Date Received
    March 11, 2009
    Report Date
    February 19, 2009
    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
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. LVP AND PCU LOGS RECEIVED BY THE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DATE OF EVENT IS UNKNOWN. CUSTOMER REPORTED OVERINFUSION OF HEPARIN IN ICU. NURSE HUNG 25,000U HEPARIN/250 ML AS PRIMARY INFUSION AT ABOUT 5 AM TO RUN AT 5 ML/HR. AT 6:40 AM SHE CHECKED AND FOUND THE BAG HALF EMPTY. NO PATIENT HARM REPORTED BUT PTT AFTER EVENT WAS GREATER THAN 230, BASELINE LEVEL NOT KNOWN. THROUGH REQUEST, NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other PCU| (B)(4)