BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 3973563 · Received August 1, 2014

    Report

    Report Number
    2015691-2014-01763
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 10, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE VAMP ADULT SYSTEM WAS RETURNED FOR EVALUATION. THE EVALUATION REVEALED THAT THE TUBING WAS FOUND DETACHED FROM THE BOND JOINT WITH THE RESERVOIR STOPCOCK. THE TUBING WAS BENT NEAR THE POINT OF DETACHMENT. THERE WERE INDICATIONS OF BONDING SOLVENT VISIBLE AT APPROXIMATELY LESS THAN 50% OF THE TUBING BOND AREA. THE TUBING OD NEAR THE POINT OF THE DETACHMENT WAS WITHIN SPECIFICATION. THE COMPLAINT WAS CONFIRMED BY EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL MANUFACTURING FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE DEVICE HISTORY REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE TUBING WAS DETACHED FROM THE VAMP DEVICE DURING USE ON A PATIENT. UNKNOWN QUANTITY OF BLEEDING WAS NOTED. THE DEVICE WAS CHANGED OUT. NO PATIENT COMPLICATIONS OR INJURY WERE REPORTED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451037 DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PXVMP260 59750709

    Patients

    Seq Age Sex Outcome Treatment
    1