BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 2220902 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16087
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    July 24, 2011
    Report Date
    July 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SINGLE DPT - VAMP ADULT KIT WAS RETURNED FOR ANALYSIS. DRY BLOOD WAS VISIBLE AT THE DISTAL TUBING CONNECTOR. THE TUBING WAS COMPLETELY DETACHED FROM THE SAMPLE SITE (Z-SITE) SOLVENT BOND JOINT. INDICATION OF BONDING SOLVENT WAS PRESENT AT A SMALL AREA OF THE TUBING BONDING SURFACE. THE OUTER DIAMETER OF THE TUBING WAS MEASURED NEAR THE POINT OF DETACHMENT AND FOUND WITHIN THE ALLOWABLE SPECIFICATION. ADDITIONALLY, THE SAMPLE SITE INNER DIAMETER WAS MEASURED AND FOUND WITHIN THE ALLOWABLE SPECIFICATION. IT APPEARED THAT THE TUBING DETACHED DUE TO INSUFFICIENT BONDING SOLVENT. VISUAL EXAMINATION WAS PERFORMED UNDER 10X MAGNIFICATION. THE REPORTED DEFECT WAS CONFIRMED TO BE A RELATED TO THE MANUFACTURING PROCESS. THIS ISSUE HAS PREVIOUSLY BEEN INVESTIGATED AND THE ROOT CAUSE WAS DETERMINED TO BE PERSONNEL NOT FOLLOWING WORK INSTRUCTIONS. THE PROCEDURE WAS ALSO REVIEWED TO DETERMINE IF THE WORK INSTRUCTION IS SUFFICIENT; NO DEFICIENCIES WERE IDENTIFIED. AWARENESS TRAINING, INCLUDING REVIEW OF THE CORRECT BONDING PROCESS, WAS PROVIDED TO THE APPLICABLE OPERATORS. BECAUSE THIS LOT NUMBER WAS NOT PROVIDED, IT IS NOT POSSIBLE TO DETERMINE IF THIS UNIT WAS MANUFACTURED BEFORE OR AFTER THE RE-TRAINING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION AT THE DROP PORT (Z-SITE) DISCONNECTED DURING USE. THE REPORTER NOTED THAT THE TUBING PROBABLY DETACHED, RATHER THAN BROKE, BUT THEY WERE NOT CERTAIN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX DISPOSABLE PRESSURE TRANSDUCER TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T001671A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1