BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 2844748 · Received October 31, 2012

    Report

    Report Number
    2016493-2012-00478
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RECEIVED, LOG REVIEW ONLY. DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED. THE EVENT LOGS HAVE BEEN RECEIVED AND THE LOG REVIEW IS PENDING. A FOLLOW UP REPORT WITH FAILURE INVESTIGATION RESULTS WILL BE SUBMITTED ONCE THE REVIEW HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FOLLOWING INFUSION WAS SET PRIOR TO THE PT ARRIVING TO THE UNIT AT 1400: NITROGLYCERINE 250 MLS BOTTLE RUNNING ON CHANNEL A AT 1.5 ML/HR. NACI 500 MLS BAG RUNNING ON CHANNEL B AT 50 ML/HR. TIROFIBAN 250MLS BAG RUNNING ON CHANNEL C AT 10.8 ML/HR. THE NEXT MORNING AT 0930, THE STAFF CHANGED THE TIROFIBAN BAG BEFORE THE PT WENT TO THE CATH LAB. WHEN THE PT ARRIVED IN THE CATH LAB AT 0945, THE CLINICIAN NOTICED THAT THE INFUSION FOR CHANNEL B AND C HAD BEEN SWOPPED. THE TIROFIBAN INFUSION WAS RUNNING ON CHANNEL B AT 50 ML/HR AND THE NACI WAS RUNNING ON CHANNEL C AT 10.8 ML/HR. THIS RESULTED IN AN OVER INFUSION OF THE TIROFIBAN AND AN UNDER INFUSION OF THE NACI. THIS FILE IS FOR THE UNDER INFUSION OF TIROFIBAN EVENT. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFO PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL 2260-006/LOT UNK| ALARIS PUMP MODULE, SN 13563841| ALARIS PC UNIT, SN 1356950| MODEL 2420-0006/LOT UNK| CHANNEL B AND C - ALARIS ADMINISTRATION SET:| CHANNEL A - ALARIS ADMINISTRATION SET:| SN 13564594