BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1905139 · Received November 22, 2010

    Report

    Report Number
    2015691-2010-14413
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 2, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRIMING SOLUTION WAS VISIBLE BUT NO BLOOD WAS FOUND INSIDE THE RETURNED DEVICES. LEAKAGES WERE CONFIRMED AROUND WELD AREA OF FLUSH DEVICES DURING LEAK TEST AT PRESSURE 300MMHG. THE CAPS WERE WELDED TO FLUSH DEVICE HOUSINGS. ENERGY LINES AROUND WELD AREA OF FLUSH DEVICE WERE MELTED. ONE CRACK, APPROXIMATELY .2" IN LENGTH, WAS ALSO FOUND AT THE WELD AREA OF BOTH FLUSH DEVICE HOUSINGS, HOWEVER LEAKAGES DID NOT OCCUR THROUGH THE CRACKS. THE REPORTED DEFECT WAS CONFIRMED TO BE A MANUFACTURING DEFECT. PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM THE UV BOND JOINT OF THE VAMP ADULT RESERVOIR. HALF OF BROKEN TUBING WAS NOT RETURNED WITH THE SYSTEM AND THE OTHER HALF WAS STILL INSIDE RESERVOIR TUBE HOUSING. ROUGH SURFACE WAS OBSERVED AT BROKEN TUBING END. IT APPEARS THAT THE BOND JOINT WAS NOT SUFFICIENTLY SECURED DUE TO INADEQUATE UV ADHESIVE. AN INVESTIGATION WAS OPENED FOR THIS ISSUE AND MULTIPLE CORRECTIVE ACTIONS WERE IMPLEMENTED. THESE INCLUDE: IN-PROCESS CHANGES, ADJUSTMENTS OF FIXTURES, REPLACEMENT OF TYPE OF BONDING, UPDATED PREVENTATIVE MAINTENANCE, AND NEW PROCESS SPECIFICATIONS/ALERT LIMITS FOR PULL STRENGTH VALUES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTEDLY, THE TRANSDUCER LEAKS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES PR CDPUNKNOWN 58780731

    Patients

    Seq Age Sex Outcome Treatment
    1