BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR.

    MDR report key: 3171151 · Received June 14, 2013

    Report

    Report Number
    2015691-2013-20356
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE VAMP JR. SYSTEM FOR EXAMINATION. DRY BLOOD WAS VISIBLE INSIDE OF THE RESERVOIR AND TUBING OF THE VAMP SYSTEM . THE PEDIATRIC TUBING WAS DETACHED FROM THE SHUT-OFF VALVE OR ONE-WAY STOPCOCK SOLVENT BOND JOINT. THE TUBING WAS BENT AT THE POINT OF DETACHMENT. INDICATION OF BONDING SOLVENT WAS PRESENT ON HALF OF THE TUBING BONDING SURFACE. THE OUTER DIAMETER OF THE TUBING WAS MEASURED AT THE POINT OF DETACHMENT AND FOUND TO BE IN SPECIFICATION. IT APPEARED THAT TUBING WAS DETACHED DUE TO INADEQUATE BONDING SOLVENT TO SECURE THE BOND JOINT. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS PENDING. A SUPPLEMENTAL REPORT WILL BE FORTH COMING. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VAMP JR WAS IN USE AT THE TIME OF THE ISSUE, LEAKAGE AND A DISCONNECT FROM THE SHUT OFF VALVE WAS NOTICED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271803 PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR. TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR VMP306PX 59377476, 59377474 OR 59254576

    Patients

    Seq Age Sex Outcome Treatment
    1