BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSURE MONITORING KIT

    MDR report key: 2052335 · Received April 12, 2011

    Report

    Report Number
    2015691-2011-15209
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE FACILITY. WITHOUT A PRODUCT TO EXAMINE, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE COMPLAINT OR IF A PRODUCT FAILURE ACTUALLY OCCURRED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REPORTED THAT THERE WAS ONLY ONE SPURT OF BLOOD THAT CAME OUT OF THE VALVE AND THE PRODUCT WAS USED WITHOUT FURTHER ISSUE AFTERWARDS. THE REPORTER INDICATED THAT THE NURSE WOULD RECEIVE THE (B)(6) TEST RESULTS IN JUNE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER BLOOD WITHDRAWAL WITH VMP400 AND TAKING THE SYSTEM FROM THE MEMBRANE, BLOOD CAME OUT OF THE MEMBRANE OF THE NEEDLELESS CANNULA. IT WAS FURTHER INDICATED THAT AFTER THE BLOOD WITHDRAWAL WITH THE VMP400 AND TAKING THE SYSTEM FROM THE MEMBRANE, THE BLOOD CAME OUT OF THE MEMBRANE FROM THE T100504A (MEMBRANE - SAMPLING-SITE). THE PATIENT HAD (B)(4) AND DUE TO THE EVENT, THE NURSE WAS CONTAMINATED IN THE FACE AND ON THE BREAST WITH BLOOD. THE SAMPLE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE MONITORING KIT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR T100504A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1