BEUDAMED
    FDA Adverse Event Death Summary report: N

    DLP SINGLE STAGE VENOUS CANNULA

    MDR report key: 2221336 · Received August 15, 2011

    Report

    Report Number
    2184009-2011-00043
    Event Type
    Death
    Date Received
    August 15, 2011
    Date of Event
    June 8, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K842375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE HISTORY COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT WHILE THIS PT WAS ON BIVENTRICULAR ASSIST DEVICE (BIVAD), DECREASED FLOW WAS NOTED. BLEEDING FROM THE CANNULA EXIT SITE WAS NOTED. THE VENOUS CANNULA WAS SEVERED IN THE WIRE WOUND SECTION OF THE CANNULA BODY, NEAR THE SUTURE RING. THE CANNULA WAS SUCCESSFULLY REPLACED AND THE PROCEDURE WAS CONTINUED WITH NO FURTHER COMPLICATIONS. SUBSEQUENTLY, INFO RECEIVED INDICATED THAT THE PT EXPIRED. THE PHYSICIAN REPORTED THE DEATH WAS NOT RELATED TO A CANNULA MALFUNCTION. THE PUMP/PERFUSION RECORDS WERE NOT AVAILABLE AND THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP SINGLE STAGE VENOUS CANNULA DWF MEDTRONIC PERFUSION SYSTEMS 69328 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death