BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3253629 · Received July 16, 2013

    Report

    Report Number
    2016493-2013-00324
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 07/16/2013. NO PRODUCT IS EXPECTED TO BE RETURNED BECAUSE THE EVENT DEVICES WERE NOT IDENTIFIED OR SEQUESTERED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PRECEDEX WAS INFUSING AT 4 ML/HR. AFTER THE VTBI COMPLETED, THE PUMP MODULE SWITCHED TO KVO AT 20 ML/HR. STATED THE PRECEDEX WAS PROGRAMMED AS A PRIMARY CONTINUOUS INFUSION USING GUARDRAILS IN THE CRITICAL CARE PROFILE. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, THE CUSTOMER DID NOT PROVIDE ANY ADD'L PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328663 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT NUMBER