BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2860666 · Received October 26, 2012

    Report

    Report Number
    2016493-2012-00474
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 27, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND LOG REVIEW IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED THE PT'S WEIGHT WAS ENTERED IN KILOGRAMS INSTEAD OF POUNDS FOR AN INFUSION OF HEPARIN. THE EVENT REPORT WAS CLARIFIED BY CLINICIAN. THE PT'S WEIGHT WAS INITIALLY ENTERED TO THE ALARIS SYSTEM IN KILOGRAMS ((B)(6)) AND REPORTED THE PT'S WEIGHT WAS FOUND TO BE ENTERED IN POUNDS ((B)(6)). THE DISCREPANCY WAS IDENTIFIED TWO DAYS AFTER PROGRAMMING. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL PT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE ADMIN SET: MODEL/LOT# UNK| ALARIS PC UNIT: SN (B)(4)