BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2842075 · Received November 14, 2012

    Report

    Report Number
    2016493-2012-00486
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO CONFIRM THE CUSTOMER'S REPORT OF NIMBEX INFUSION WAS RE-STARTED INSTEAD OF STARTING THE ANTIBIOTIC FLAGYL. THE CUSTOMER STATED THAT NO DEVICES WILL BE RETURNED AND THAT THEY DO NOT REQUIRE A LOG REVIEW. THE NURSE UNDERSTANDS WHAT HAPPENED AND DOES NOT WANT AN EVENT LOG REVIEW OR NEEDS TO HAVE THE DEVICE CHECKED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PATIENT RECEIVED NIMBEX INSTEAD OF FLAGYL. SHE STATED THAT THE NIMBEX DRIP WAS MISTAKENLY INFUSING FOR ABOUT 1 HOUR AND AN ESTIMATED VOLUME THAT WAS INFUSED WAS 100ML. IT WAS REPORTED THAT THE NIMBEX HAD BEEN DISCONTINUED, BUT THE BAG AND TUBING HAD BEEN LEFT IN LACE AND THEN WHEN THE NURSE INTENDED TO GIVE FLAGYL, THE NIMBEX SET UP WAS USED BY MISTAKE. THE NURSE PROVIDED ADDITIONAL INFORMATION STATING THAT DUE TO THE MEDICATION ERROR THE PATIENT RECEIVED EXTRA MUSCLE RELAXANT REQUIRING ADDITIONAL SEDATION WITH IV VERSED (AMOUNT UNSPECIFIED) AND REMAINED ON THE VENTILATOR LONGER THAN EXPECTED. THE PATIENT WAS IN THE SURGICAL INTENSIVE CARE UNIT AND WAS POST OP FROM A PROCEDURE (UNSPECIFIED). THE NURSE REPORTED THE PATIENT FULLY RECOVERED FROM THE EVENT. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PATIENT OR EVENT DETAILS.

    Devices

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

    Patients

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