BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT

    MDR report key: 2071244 · Received April 27, 2011

    Report

    Report Number
    2015691-2011-15349
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE ALTHOUGH THE ESTIMATED BLOOD LOSS WAS NOT QUANTIFIABLE, THERE WAS NO PATIENT INJURY AS A RESULT. THE ALARM ON THE MONITOR RANG WHEN THE ARTERIAL LINE DISAPPEARED AND THIS OCCURRED "OVER A MINUTE OR SO IT IS THOUGHT".

    Additional Manufacturer Narrative · 1

    RECEIVED (1) INCOMPLETE VAMP ADULT SYSTEM. DRY BLOOD WAS VISIBLE THROUGHOUT THE SYSTEM. THE ACTUAL COMPLAINT WAS NOT CONFIRMED; THE TUBING DID NOT BREAK BUT WAS COMPLETELY DETACHED FROM THE SOLVENT BOND JOINT WITH THE Z-SITE. THE DETACHED TUBING WAS NOT RETURNED WITH THE VAMP SYSTEM. INDICATION OF BONDING SOLVENT WAS VISIBLE AT SMALL PART OF Z-SITE BOND AREA. THE INNER DIAMETER OF THE Z-SITE TUBE HOUSING (BOND AREA) WAS MEASURED AND FOUND WITHIN THE ALLOWABLE SPECIFICATION. IT WAS NOT POSSIBLE TO MEASURE THE TUBING OUTER DIAMETER OR THE BONDING CONDITION OF THE DETACHED TUBING SINCE THE TUBING WAS NOT RETURNED WITH THE SYSTEM. VISUAL EXAMINATION WAS PERFORMED UNDER 10X AND 40X MAGNIFICATION. THE TUBING DETACHMENT OCCURRED ON THE PATIENT SIDE OF THE PRESSURE MONITORING KIT. THE REPORTED DEFECT WAS CONFIRMED TO BE RELATED TO THE MANUFACTURING PROCESS. ACTIONS WERE OPENED TO ADDRESS COMPLAINTS OF THIS TYPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING BROKE OFF BELOW THE Z SITE AND THE PATIENT STARTED BLEEDING. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE MONITORING KIT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PXVMP120 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1