BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3862993 · Received June 4, 2014

    Report

    Report Number
    2016493-2014-00271
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    February 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED. THIS REPORT WAS FILED BY THE MFR. ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED WITH EVALUATION RESULTS SHOULD THE DEVICE BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NOREPINEPHRINE BAG HAD LESS VOLUME THAN IT SHOULD HAVE HAD AND THE CUSTOMER SUSPECTS POSSIBLE FREE FLOW OCCURRED DURING CABG SURGERY. THE NOREPINEPHRINE BAG CONCENTRATION WAS 8MG/250ML. THE INFUSION WAS STARTED AT 1002 AT 0.03MCG/KG/MIN AND THE RATE WAS 4.8ML/HOUR. THE INFUSION WAS STOPPED AT 1003 DUE TO THE BLOOD PRESSURE RISING FROM 150/90 TO 230/100. THE BLOOD PRESSURE WAS TREATED WITH MEDICATIONS AND RETURNED TO BASELINE LEVELS. THE PT'S CONDITION RETURNED TO STABLE. THE NURSE NOTED ALMOST HALF OF THE NOREPINEPHRINE BAG WAS INFUSED WHEN IT SHOULD NOT HAVE BEEN. THE NURSE TESTED THE PUMP AFTER THE PROCEDURE WITH A NORMAL SALINE BAG AND NOTED FREE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326142 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PC UNIT SN (B)(4)| PUMP MODULE ADMINISTRATION SET, MODEL/LOT # UNK