BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSION ADAPTER

    MDR report key: 1672258 · Received April 30, 2010

    Report

    Report Number
    2184009-2010-00006
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 1, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTL
    PMA / PMN Number
    K790564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4), EVALUATION RESULTS = DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS THE SERIAL NUMBER WAS UNAVAILABLE AND NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. THE USER FACILITY MEDWATCH RECEIVED STATED THAT AN ADAPTOR ON THIS PRODUCT SNAPPED WHILE THE PT WAS BEING MOVED. BASED ON THIS, IT APPEARS THAT THE PRODUCT MAY HAVE GOTTEN CAUGHT ON SOMETHING WHILE MOVING THE PT. THE ADAPTER ON THIS PRODUCT IS AN ACRYLIC PART AND IS THE LEAST FLEXIBLE PART OF THE PRODUCT. IF THE DEVICE WERE TO BE CAUGHT ON SOMETHING AND WERE TO BREAK, IT WOULD BREAK AT THE ADAPTOR, AS IN THIS REPORTED EVENT. SINCE NO PRODUCT WAS RETURNED FOR ANALYSIS, NO FURTHER INVESTIGATION CAN BE PERFORMED. BASED ON WHAT IS KNOWN AT THIS TIME, IT WAS SPECULATED THAT THE CAUSE OF THIS EVENT WAS LIKELY TO BE A USER-RELATED ISSUE.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION ADAPTER DTL MEDTRONIC PERFUSION SYSTEMS 10007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1