BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESCIENCES

    MDR report key: 1031623 · Received April 17, 2008

    Report

    Report Number
    MW5006311
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE HAVE BEEN 4 REPORTED INSTANCES OF TUBING SEPARATING FROM THE BLOOD COLLECTION DEVICE ALSO CALLED THE VAMP (VENOUS ARTERIAL BLOOD MANAGEMENT SYSTEM). THE DATES OF OCCURRENCE WERE 2007, 2008. THE TUBING SEPARATION OCCURRED WITH BOTH THE FLOW TRACK AND NON FLO TRACK TUBING. IN ALL INSTANCES THE TUBING SEPARATED FROM THE VAMP IN THE SAME PLACE. IN THE MOST RECENT CIRCUMSTANCE, THE TUBING SEPARATED AT THE VAMP DISTAL TO THE END OF THE TUBING CLOSEST TO THE PT. THE NURSE IMMEDIATELY CLOSED OFF THE STOPCOCK AND CHANGED THE TUBING. THE PT DID NOT REQUIRE FURTHER TREATMENT. THIS REPORT IS BASED ON PRELIMINARY INFO RECEIVED BY A MEDICAL CENTER WHICH HAS NOT HAD THE OPPORTUNITY TO INVESTIGATE OR VERIFY PRIOR TO THE REPORTING DATE. MEDICAL CENTER HAS NOT CONCLUSIVELY DETERMINED THE CAUSE OF THIS EVENT. IN ADDITION, THE SUBMISSION OF THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION THAT A REPORTABLE EVENT HAS IN FACT OCCURRED. SYSTEM WAS USED WITH A PRESSURE BAG PUMPED UP TO 300MHG PER STANDARD, TO MAINTAIN THE 3CC/HR FLUSH. LOT STOCK ON FLOOR AT TIME OF OCCURRENCE WAS SIMILAR TO ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCES TRANDUCER SINGLE FLUSH SET AND SENSOR FLOW TRACK WITH VAMP DRS EDWARDS LIFESCIENCES PXVMP160 58456980

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention