BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1990220 · Received February 15, 2011

    Report

    Report Number
    2015691-2011-14801
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VAMP PLUS WITH PRESSURE TUBING LINE INCLUDING THREE Z-SITES WAS RECEIVED FOR EVALUATION. NO PRIMING SOLUTION WAS VISIBLE. THE REPORTED DEFECT WAS CONFIRMED. THE TUBING WAS DETACHED FROM SOLVENT BOND JOINT AT PATIENT SIDE Z-SITE. INDICATION OF BONDING SOLVENT WAS PRESENT AT SMALL PART OF TUBING BOND AREA. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. DAMAGE OCCURRED ON PATIENT SIDE OF THE KIT. RISK ASSESSMENT HAS BEEN CONDUCTED FOR THIS CONDITION. AS CUSTOMER COMPLAINT WAS CONFIRMED AWARENESS TRAINING IS BEING CONDUCTED AT OUR MANUFACTURING PLANT IN ADDITION TO ASSIGNING A CROSS-FUNCTIONAL TEAM TO INVESTIGATE THESE TYPE OF OCCURRENCES IN ORDER TO DETERMINE A ROOT CAUSE AND TAKE ACTIONS AS DEEMED NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE LOT NUMBER WAS UNKNOWN.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETE AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TUBING CONNECTED TO THE Z-SITE CAME OFF AT THE CONNECTION IN CORONARY CARE UNIT - SURGERY (CCU-S) BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PRESSURE TRANSDUCER CUSTOM VAMP PLUS 12CC DRS EDWARDS LIFESCIENCES DR CDPUNKNOWN 58906629

    Patients

    Seq Age Sex Outcome Treatment
    1