BEUDAMED
    FDA Adverse Event Other Summary report: N

    RUBY MEM MORGANTOWN,WV1

    MDR report key: 823318 · Received January 30, 2007

    Report

    Report Number
    1718850-2007-00001
    Event Type
    Other
    Date Received
    January 30, 2007
    Date of Event
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWE
    PMA / PMN Number
    k981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THIS ISSUE WAS NOT AVAILABLE FOR EVALUATION. TWO PACKS FROM THE SAME LOT NUMBER WERE PULLED FROM INVENTORY, INSPECTED AND TESTED. THE CONNECTION IN QUESTION WAS BUILT TO PRINT SPECIFICATION. A CIRCUIT WAS SET UP USING THE PACK FROM INVENTORY AND RUN FOR SIX HRS. THE TUBING AT THE CONNECTOR WAS THEN STRESSED IN AN ATTEMPT TO DUPLICATE THE DISCONNECTION REPORT. THE TUBING IN THE PACK WAS IN INVENTORY AND WAS MEASURED AND CONFIRMED TO MEET SPECIFICATION. ALTHOUGH THE ISSUE COULD NOT BE DUPLICATED AND NO ISSUES WERE FOUND IN THE PACKS FROM INVENTORY, THE PRINT SPECIFICATION FOR THE HEART-LUNG PACK HAS BEEN UPDATED TO ADD SOLVENT AND CHANGE THE TUBING TYPE AT THE CUSTOMER'S REQUEST.

    Description of Event or Problem · 1

    THE PT WAS OFF BYPASS AND THE PERFUSIONIST WENT TO TEAR DOWN THE CIRCUIT. THE TUBING DISCONNECTED FROM THE OUTLET OF THE VENOUS RESERVOIR GETTING BLOOD ON THE SHOES, SOCKS OF THE PERFUSIONIST. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUBY MEM MORGANTOWN,WV1 CUSTOM HEART LUNG PERFUSION PACK DWE SORIN GROUP USA, INC. NA 0625400027

    Patients

    Seq Age Sex Outcome Treatment
    1 *