BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SE INFUSION PUMP

    MDR report key: 830944 · Received March 20, 2007

    Report

    Report Number
    MW1042289
    Event Type
    Malfunction
    Date Received
    March 20, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 13, 2007
    Manufacturer
    CARDINAL HEALTH 303 INC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CVICU NURSE REPORTED A KEY BOUNCE INCIDENT OCCURRING TWICE WHILE PROGRAMMING INFUSION PUMP. THE NURSE REPORTED USING A 0.5 SETTING IN WHICH THE 5 KEY DOUBLE BOUNCED AND SO DID THE ZERO KEY. BIO-MED CHECKED OUT THE PUMP BUT WAS UNABLE TO DUPLICATE THE INCIDENT. NO PATIENT INJURY OCCURRED. NURSING STAFF HAS BEEN INFORMED OF HEALTH ALERT RE: KEY BOUNCE ISSUE AND RECOMMENDATIONS BY CARDINAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SE INFUSION PUMP MEDICATION INFUSION PUMP FRN CARDINAL HEALTH 303 INC 72306 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *