BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTRAC SENSOR

    MDR report key: 3211051 · Received July 8, 2013

    Report

    Report Number
    2015691-2013-20553
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    PMA / PMN Number
    K043065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SINGLE COMPLETE FLOTRAC VAMP KIT WAS RETURNED FOR EVALUATION. PRIMING SOLUTION WAS VISIBLE IN THE KIT. THE PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM THE SOLVENT BOND JOINT WITH THE DISTAL SAMPLE SITE. INDICATIONS OF BONDING SOLVENT WERE PRESENT ON A SMALL PART OF THE BOND AREA OF THE TUBING. NO RESIDUAL BONDING SOLVENT WAS PRESENT AT THE Z-SITE TUBE HOUSING. THE OUTER DIAMETER OF THE TUBING AND THE INNER DIAMETER OF THE Z-SITE TUBE HOUSING WAS MEASURED AND FOUND WITHIN SPECIFICATION. THE COMPLAINT WAS CONFIRMED AND IS RELATED TO A MANUFACTURING NON-CONFORMANCE. A CAPA IS OPEN TO ADDRESS COMPLAINTS OF THIS TYPE. IN ADDITION, ALL PERSONNEL INVOLVED WITH THE SOLVENT BONDING PROCESS WERE NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE PRESSURE LINE WAS FOUND DISCONNECTED (SEPARATED), JUST BEFORE THE Z-SITE. FOLLOW UP CONFIRMED THAT THE TUBING WAS DETACHED AND THE TUBING ENDS WERE SMOOTH. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310021 FLOTRAC SENSOR FLOTRAC SENSOR DRS EDWARDS LIFESCIENCES DR MHD6AZR 59397218

    Patients

    Seq Age Sex Outcome Treatment
    1