BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFLOW

    MDR report key: 3200087 · Received May 29, 2013

    Report

    Report Number
    8020616-2013-00007
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD
    Product Code
    FOZ
    PMA / PMN Number
    K033500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT OBSERVED THAT FLOSWITCH SLIDE BUTTON WAS MISSING, SUGGESTED THAT IT WAS BEING DETACHED FROM THE FLOSWITCH HOUSING DUE TO BROKEN BUTTON RIBS. THE STANDALONE FLOSWITCH SHOWED BROKEN RIBS ON THE FLOSWITCH BUTTON AT THE SIDE OF THE "ON/ OFF" IMPRINT RENDERING IT UNABLE TO SECURE TO THE FLOSWITCH HOUSING GROOVE DURING SLIDING. FAILURE ANALYSIS CONDUCTED THROUGH SIMULATION STUDIES OF THE POTENTIAL ROOT CAUSE TO THE BROKEN RIB OF THE FLOSWITCH CONCLUDED THAT THE COMBINE FACTORS OF THE DEVICE BEEN CONTACTED WITH CHEMICAL DISINFECTANTS AND THE FLOSWITCH WAS "FORCE" TO THE "OFF" POSITION WHEN HARD OBJECT SUCH AS STEEL NEEDLE REMAINED PARTIALLY INSIDE THE DEVICE DURING PRODUCT APPLICATION. REVIEWED OF THE MANUFACTURING PROCESS SHOWED THAT THE FLOSWITCH ASSEMBLY GOES THROUGH 100% VISUAL AND FUNCTIONAL TESTS TO DETECT ANY ISSUES ASSOCIATED WITH THE INTEGRITY OF FLOSWITCH DURING ASSEMBLY PROCESS. BASED ON THE ABOVE EVALUATION AND CONCLUSION, EUROPE SALES IS RECOMMENDED TO INFORM USER NOT TO SWITCH THE FLOSWITCH TO THE "OFF" POSITION WHEN A HARD OBJECT WAS STILL INSIDE THE DEVICE. AS STATED IN INSTRUCTION FOR USE, FLOSWITCH SHOULD NOT BE SWITCHED "OFF" BEFORE THE NEEDLE HAS BEEN FULLY WITHDRAWN AND ENSURE FLOSWITCH IS IN "ON" POSITION PRIOR TO INJECTING OR REMOVING NEEDLE.

    Description of Event or Problem · 1

    DURING USE, NURSING STAFF IDENTIFIED THAT THE SWITCH MECHANISM OF THE FLOSWITCH HAD BROKEN AND FALLEN OFF THE FLOSWITCH BODY. LEAVING THE CATHETER AT RISK OF BEING OPEN. REPLACEMENT FLOSWITCH ADDED TO INTEGRAL FLOSWITCH BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237132 CAREFLOW CENTRAL VENOUS CATHETER KIT FOZ ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD 208575

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #204876| CAREFLOW 1 LUMEN 5FRX150MM: CATALOG #681664