BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE BIFUSE EXT. SET

    MDR report key: 4736556 · Received April 28, 2015

    Report

    Report Number
    2025816-2015-00038
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 6, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: ONE (1) USED 011-MC3316 WAS RETURNED TO THE MFR. ALTHOUGH REQUESTED, THE INVOLVED MATING AND ACCESS DEVICES WERE NOT RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE "AS-RECEIVED" 011-MC3316 DEVICE SET RECORDED 1 OF SETS 2 MICROCLAVE CONNECTORS SILICONE PLUG WAS DAMAGED/PROTRUDING. THE REPORTED ISSUE WAS VISUALLY CONFIRMED. LOT BUILD REVIEW: A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED 011-MC3316, LOT# 2913371 (MFG 08/2014) SHOWED (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. ENGINEERING EVALUATIONS: ALTHOUGH NOT ALWAYS REPEATABLE PREVIOUS ENGINEERING ANALYSIS OF SILICONE PLUG PROTRUSIONS HAVE BEEN REPLICATED UNDER CERTAIN USAGE CONDITIONS WHERE THE MICROCLAVE CONNECTOR IS EXPOSED TO HIGH BACK PRESSURES. HIGH PRESSURES CAN BE GENERATED WITH SMALL SYRINGES (10CC AND SMALLER). WHEN HIGH PRESSURES ARE GENERATED WITH INFUSION OR FLUSHING THROUGH SMALL SYRINGES, IT IS IMPORTANT TO ISOLATE ADJACENT LINES BY ACTIVATING THE SLIDE CLAMPS ON THOSE LINES. INVESTIGATIONS HAVE ALSO IDENTIFIED MICROCLAVE COMPONENT DAMAGES CAN OCCUR IF THE CONNECTOR IS ACCESSED/MATED WITH AN INCOMPATIBLE MATING DEVICE. AS STATED ON THE MICROCLAVE DIRECTIONS FOR USE (DFU) ,THE CONNECTOR SHOULD ONLY BE ACCESSED WITH AN ISO COMPLAINT MALE LUER WITH AN INSIDE DIAMETER BETWEEN 1.55 MM - 2.8 MM. FINDINGS: BASED ON THE ENGINEERING EVALUATION OF THE "AS-RECEIVED" 011-MC3316 DEVICE SETS MICROCLAVE CONNECTOR THE REPORTED PRODUCT/COMPONENT ISSUE WAS VERIFIED. ALTHOUGH THE EXACT CAUSES OF THE COMPONENT ANOMALY ARE UNK, THE MOST LIKELY CAUSE OF THIS ISSUE WAS DUE TO USAGE CONDITIONS WHERE SET-UPS/INFUSIONS OCCURRED WITH VERY HIGH BACK PRESSURES WITHIN THE FLUID CIRCUIT.

    Description of Event or Problem · 1

    INT'L. (B)(6) COMPLAINT RECEIVED REPORTING COMPONENT/PLUG PROTRUSION WITH USE OF 011-MC3316 7" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE CLEAR. IT WAS REPORTED THAT ".. INCIDENT THAT TOOK PLACE ON A CENTRAL VENOUS CATHETER WHEN REMOVING AN INFUSION, THE SPRING CAME OFF.." THERE WERE NO PT INJURIES/ADVERSE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279309 SMALLBORE BIFUSE EXT. SET SMALLBORE BIFUSE EXT. SET FPA ICU MEDICAL, INC. 011-MC3316 2913371

    Patients

    Seq Age Sex Outcome Treatment
    1 CV CATHETER,| SYRINGE SIZE/TYPE UNK