BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP VEN

    MDR report key: 3111404 · Received May 14, 2013

    Report

    Report Number
    2015691-2013-20072
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 19, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE SHORT WIPER GASKET WAS RELATED TO THE MOLDING OF THE SEAL AT THE COMPONENT SUPPLIER. A NEW MOLD WAS QUALIFIED AND IMPLEMENTED AT THE END OF (B)(6) 2013. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE VAMP ADULT SYSTEM FOR EXAMINATION. DRY BLOOD WAS VISIBLE INSIDE OF THE VAMP SYSTEM. DRY BLOOD WAS EVIDENT ON THE PLUNGER SIDE OF THE BLUE SEAL AND ON THE INSIDE OF THE CONTAMINATION SHIELD. BLOOD WAS EVIDENT BETWEEN THE SEAL AND RESERVOIR. IT WAS APPARENT THAT BLOOD HAD LEAKED PAST THE BLUE SEAL TO THE PLUNGER SIDE AND OUT OF THE RESERVOIR CAP INTO THE CONTAMINATION SHIELD. A SIMULATED USE TEST WAS PERFORMED TO THE VAMP SYSTEM IN ATTEMPT TO RECREATE HOW BLOOD PASSED THE SEAL INTO PLUNGER SIDE. THERE WAS NO LEAKAGE DETECTED PAST THE SEAL DURING SIMULATED USE TEST IF IFU RECOMMENDATIONS WERE FOLLOWED. IT IS RECOMMENDED BY IFU TO SMOOTHLY AND EVENLY MOVE THE PLUNGER AT RATE OF 5ML PER 3-5 SECONDS DURING ASPIRATION AND INJECTION OF BLOOD FROM THE RESERVOIR. AIR LEAKED PAST THE SEAL DURING ASPIRATION AND FLUID LEAKED PAST THE SEAL DURING INJECTION IF THE PLUNGER WAS PULLED AND PUSHED UNEVENLY. LEAKAGE OCCURRED AT ONLY ONE LOCATION OF THE SEAL. THE SEAL AND ATTACHED PLUNGER WERE REMOVED FROM THE RESERVOIR FOR VISUAL EXAMINATION. THE WIPER OF THE SEAL AT LOCATION OF LEAKAGE APPEARED SHORTER THAN EXPECTED. IT WAS NOT POSSIBLE TO COMPARE THE SEAL DIMENSIONS WITH THE APPLICABLE DRAWING BECAUSE THE SEAL WAS NOT IN IT'S ORIGINAL CONDITION; AFTER ASSEMBLY, THE SEAL IS COMPRESSED INSIDE THE RESERVOIR. AN INVESTIGATION IS CURRENTLY OPEN TO DETERMINE THE ROOT CAUSE OF THE SHORT WIPER SEAL AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT THE SHIELD OVER THE HANDLE/PLUNGER HAD BLOOD INSIDE THE CASING. THIS HAPPENED ON THE SAME PATIENT WITH TWO DIFFERENT DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212613 PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP VEN TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR PXAVMP 59430369

    Patients

    Seq Age Sex Outcome Treatment
    1