BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAMP PLUS TRIPLE CUSTOM DEFINED PRODUCT PM

    MDR report key: 2250307 · Received September 15, 2011

    Report

    Report Number
    2015691-2011-16178
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE TRIPLE DPT - VAMP PLUS KIT FOR EXAMINATION. PRIMING SOLUTION WAS VISIBLE INSIDE THE KIT; HOWEVER, THE KIT DID NOT APPEAR TO BE USED. THE VENTED CAPS WERE STILL ATTACHED AT THE DISTAL MALE CONNECTOR WHICH ATTACHES TO THE PATIENT. THERE WAS NO VISIBLE BLOOD FOUND AT THE DISTAL TUBING MALE CONNECTORS. AS RECEIVED, THE ONE-WAY STOPCOCK (SHUT-OFF VALVE) WAS SEPARATED OR DETACHED FROM THE VAMP RESERVOIR. THERE WAS NO PRESENCE OF UV ADHESIVE AT THE PRIMARY BOND JOINT BETWEEN STOPCOCK MALE LUER AND THE RESERVOIR. THERE WAS ALSO NO PRESENCE OF UV ADHESIVE AT SECONDARY BOND JOINT BETWEEN STOPCOCK HOUSING AND RESERVOIR. IT APPEARED THAT THE STOPCOCK DID NOT GET BONDED DURING THE BONDING PROCESS. THE STOPCOCK DETACHMENT OCCURRED ON PATIENT SIDE OF THE KIT. VISUAL EXAMINATION WAS PERFORMED AT 10X MAGNIFICATIONS. THE STOPCOCK DETACHMENT WAS CONFIRMED TO BE RELATED TO THE MANUFACTURING PROCESS. THE ROOT CAUSE HAS BEEN IDENTIFIED AND ACTIONS ARE BEING IMPLEMENTED IN THE MANUFACTURING PROCESS TO PREVENT RECURRENCE OF THIS TYPE OF COMPLAINT. THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRIMING, WHILE DRAWING UP FLUID FROM THE SYRINGE, IT WAS NOTICED THAT THE TUBING BROKE OFF FROM THE CONNECTOR. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAMP PLUS TRIPLE CUSTOM DEFINED PRODUCT PM DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PXVP0550 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1