BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 802020 · Received January 4, 2007

    Report

    Report Number
    MW1041553
    Event Type
    Malfunction
    Date Received
    January 4, 2007
    Date of Event
    December 26, 2006
    Report Date
    January 3, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PUMP HAD LEFT ED WITH PUMP SET @ 8ML/HR. CHECKED BY 2 RN'S. AMOUNT INFUSED WAS 37ML MORE THAN SHOULD HAVE BEEN INFUSED. IV MED WAS HEPARIN. PMD WAS NOTIFIED AND 2-HOUR NEURO CHECKS WERE INTIATED. PT RETURNED FROM CT WITH IV PUMP BEEPING. UPON CHECKING PUMP, RN FOUND IV RATE SET @ 999 ML/HR. PUMP WAS USED NEXT TO CT UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS INFUSION PUMP FRN CARDINAL HEALTH 7100J *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR