BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 7142787 · Received December 22, 2017

    Report

    Report Number
    2016493-2017-00739
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 28, 2017
    Report Date
    November 30, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED. THE CUSTOMER¿S REPORT OF AN OVERINFUSION WAS CONFIRMED. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT ON (B)(6) 2017 AT 8:14 PM THE USER ENTERED 50MCG FOR THE DRUG AMOUNT (RATHER THAN THE INTENDED 2,500 MCG) AND 50ML FOR THE DILUENT VOLUME FOR FENTANYL CONT INFUS WEIGHT BASED DOSING. THESE PARAMETERS MADE THE CONCENTRATION 1MCG/ML AND THE RATE 99.8ML/HR. THE INFUSION CONTINUED AT THIS RATE UNTIL THE DEVICE WAS CHANNELED OFF AT 8:35 PM. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 31.232ML. THE ROOT CAUSE OF THE OVERINFUSION WAS USER PROGRAMMING. NO DEVICE WAS RETURNED FOR INVESTIGATION. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    AFTER THE EVENT, THE PHARMACIST REQUESTED AN EVENT LOG REVIEW TO CHECK PROGRAMMING FOR A POSSIBLE OVER INFUSION, STATING THAT THE USER MAY HAVE ENTERED THE DRUG INCORRECTLY. ALTHOUGH REQUESTED, NO OTHER EVENT DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FENTANYL, (2,500 MCG/50 ML) WAS EXPECTED TO INFUSE AT A DOSE OF 1 MCG/KG Q 30 MINUTES, MAX OF 10 MCG/KG/HR. THE PATIENT¿S WEIGHT WAS (B)(6). NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922764 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1