BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2251730 · Received August 31, 2011

    Report

    Report Number
    2016493-2011-00485
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOGS REC'D, LOG REVIEW PENDING. THE EVENT LOGS HAVE BEEN REC'D. A F/U REPORT WILL BE SUBMITTED ONCE THE EVENT LOGS HAVE BEEN EVALUATED AND A FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ALARIS SYSTEM WITH FOUR PUMP MODULES WAS IN USE WHEN CHANNEL A WITH AN AMIODARONE DRIP WAS FOUND TO BE SCROLLING "INFUSION COMPLETE" W/O AN AUDIO ALARM. THE CLINICIAN DID NOT KNOWN THE INFUSION HAD FINISHED AND THE PT WAS W/O MEDICATION FOR APPROX 30 MINS. THERE WAS NO REPORT OF PT HARM. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR THREE ADD'L ALARIS PUMP MODULES, S/N'S UNK| ALARIS PC UNIT: SN (B)(4)| ALARIS ADMINISTRATION SET: MODEL/LOT UNKNOWN