BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE IV EXTENSION SET

    MDR report key: 3619278 · Received November 18, 2013

    Report

    Report Number
    2025816-2013-00131
    Event Type
    Malfunction
    Date Received
    November 18, 2013
    Date of Event
    October 10, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INT'L. (B)(4) COMPLAINT RECEIVED CONCERNING OCCLUSION/FLOW ISSUES DURING EMERGENT PROCEDURE WITH USE OF B2140, 72" SMALL BORE EXT SET. IT WAS REPORTED THAT WHEN "... INFUSING IV MED PUMP RANG OCCLUDED. IV SITE PT, TUBING CHANGED X 3. WHEN FLUSHING TUBING RESISTANCE FELT. CHANGED TUBING TO ... ZERO OCCLUSION DETECTED FLUSHED MORE EASILY." TREATMENT RESUMED WITH SET-UP CHANGE. NO REPORTED ADVERSE PT CONSEQUENCES. THE MANUFACTURER HAS BEEN ADVISED THE INVOLVED B2140 DEVICE SET WAS RETAINED BUT THE INVOLVED MATING/ ACCESS DEVICES (MFR, MAKE OR MODEL UNK) ARE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. ADDITIONAL EVENT/USAGE INFORMATION HAS ALSO BEEN REQUESTED BUT AS OF THE DATE OF THIS REPORT NO RESPONSES HAVE BEEN PROVIDED. MFG'S INITIAL INVESTIGATION: A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT #2711173 (MFG DATE 07/01/2013) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597178 SMALLBORE IV EXTENSION SET SMALLBORE IV EXTENSION SET FPA ICU MEDICAL INC. B2140 2711173

    Patients

    Seq Age Sex Outcome Treatment
    1 NI