BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2961000 · Received January 16, 2013

    Report

    Report Number
    2016493-2013-00067
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 31, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT LOGS AND DATA SET HAVE BEEN REC'D AND LOG REVIEW IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. NO DEVICES REC'D, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED AN EVENT LOG REVIEW FOR AN OVERINFUSION FENTANYL. HE REPORTED THAT THE PT WAS SUPPOSED TO RECEIVE 5CC OF FENTANYL PER HOUR BUT ACTUALLY REC'D 50CC OF FENTANYL PER HOUR FOR APPROXIMATELY 2 HOURS ON (B)(6) 2012 AROUND 6 PM. THE NURSE STATED THE DOSING MISTAKE WAS NOTICED AT SHIFT CHANGE BY THE NURSE TAKING OVER CARE OF THE PT. SHE REPORTED IT WAS A PRIMARY INFUSION AND THAT THE TUBING WAS DISCARDED. SHE DID NOT KNOW THE CONCENTRATION OF FENTANYL USED OR THE VOLUME THAT WAS USED. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADD'L EVENT OR PT INFO PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23928 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODLE ADMIN SET: MODEL/LOT# UNK