BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3682999 · Received March 5, 2014

    Report

    Report Number
    2016493-2014-00130
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 18, 2014
    Manufacturer
    CARDINAL HEALTH 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVERINFUSION OF FENTANYL. DETAILS ARE AS FOLLOWS: FENTANYL 200 MCG / 100 ML WAS STARTED AT 02:45 TO INFUSE VIA PRIMARY PORT OF UVC. RATE WAS 0.7 ML/H (=0.5 MCG/KG/HR, PATIENT WEIGHT (B)(6)) AND VTBI WAS 4 ML; 10 ML HAD BEEN WASTED DURING PRIMARY THEREFORE 90 ML REMAINED IN THE BAG. AT 03:49 THE RN NOTICED THAT THE BAG WAS EMPTY WITH AIR IN THE IV TUBING FROM THE BAG TO THE PUMP ALTHOUGH THE PUMP'S VOLUME INFUSED READ ONLY 0.78 ML. NO LEAK WAS FOUND. THE INFUSION WAS STOPPED AND THE PATIENT WAS GIVEN MEDICATION TO COUNTERACT THE FENTANYL. OVERINFUSION WAS REPLICATED BY THE HOSPITAL BIOMED WITH DIFFERENT SETS AND AT DIFFERENT RATES. IT WAS REPORTED THAT THE INFUSION DID NOT STOP WHEN THE PAUSE BUTTON WAS PRESSED AND THE MOTOR COULD BE HEARD RUNNING AT "A HIGH RATE OF SPEED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131970 ALARIS PUMP MODULE FRN CARDINAL HEALTH 303, INC. 8100 NA

    Patients

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