BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINED PRODUCT

    MDR report key: 3232776 · Received July 18, 2013

    Report

    Report Number
    2015691-2013-20631
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 5, 2013
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED ONE SINGLE DPT-VAMP ADULT KIT WITH IV SET AND PRESSURE TUBING. THE IV TUBE WAS CUT AND THE SPIKE WAS NOT RETURNED FOR EVALUATION. 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 ITS ORIGINAL CONDITION; AFTER ASSEMBLY, THE SEAL IS COMPRESSED INSIDE THE RESERVOIR. 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 JANUARY 2013. BECAUSE THE LOT NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE IF THE UNIT WAS MANUFACTURED BEFORE OR AFTER THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "BLOOD LEAKAGE WAS OBSERVED FROM THE VAMP ADULT RESERVOIR DURING USE." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333574 CUSTOM DEFINED PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR VB1903TSVO(PL)_

    Patients

    Seq Age Sex Outcome Treatment
    1