BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 6362504 · Received February 27, 2017

    Report

    Report Number
    2016493-2017-00175
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 14, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 2426-0500; HOSPIRA 100 ML BOTTLE OF PRECEDEX (DEXMEDETOMIDINE HCL IN 0.9% SODIUM CHLORIDE INJECTION), NDC 0409-1660-10, LOT # 68165DD, EXP DATE: 1 AUG 2018; THERAPY DATE (B)(6) 2017. THE CUSTOMER¿S REPORT THAT AN INFUSION OF DEXMEDETOMIDINE WAS FOUND EMPTY PREMATURELY COULD NOT BE CONFIRMED OR DUPLICATED. THE PCU EVENT LOG SHOWED THAT AT 10:23PM ON (B)(6) 2017 AN INFUSION OF DEXMEDETOMIDINE 400MCG/100ML WAS STARTED WITH THE RATE AT 4.45ML/HR AND VTBI AT 100ML. THE USER INCREASED THE DOSE FROM 0.2MCG/KG/HR TO 0.4MCG/K/HR AT 10:48PM WHICH INCREASED THE RATE TO 8.9ML/HR. THE USER INCREASED THE DOSE AGAIN APPROXIMATELY TWENTY MINUTES LATER TO 0.6MCG/KG/HR (RATE 13.4ML/HR). ON (B)(6) 2017 AT 12:22AM THE USER DECREASED THE DOSE TO 0.5MCG/KG/HR (RATE 11.1ML/HR). THE PUMP MODULE ALARMED FOR AIL AT 2:57AM AND WAS TURNED OFF. THE TOTAL CALCULATED VOLUME INFUSED WAS 49.812ML. THE CAUSE FOR THE EARLY TERMINATION OF THE INFUSION COULD NOT BE ASCERTAINED FROM THE LOG ANALYSIS. THE INCREASE IN THE RATE OF THE INFUSION WAS NOT A CONTRIBUTING FACTOR. RATE ACCURACY TESTING INDICATED THE DEVICE WAS INFUSING WITHIN SPECIFICATIONS. NO LEAKING WAS NOTED FROM THE TUBING. THE ROOT CAUSE OF THE INFUSION BEING FOUND EMPTY PREMATURELY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT WAS RECEIVING DEXMEDETOMIDINE 400 MCG/100 ML WITH AN INTENDED RATE OF 4.45 ML/HR. INITIATED AT 10:24 PM. THE BAG WAS FOUND EMPTY AT 3:00 AM AND IT WAS NOTED THE PUMP READ THAT 50 ML WAS LEFT TO INFUSE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145017 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 PRI TUBING,8015, THERAPY DATE(B)(6) 2017