BEUDAMED
    FDA Adverse Event Death Summary report: N

    DLP SINGLE STAGE VENOUS CANNULA

    MDR report key: 2142448 · Received June 15, 2011

    Report

    Report Number
    2184009-2011-00037
    Event Type
    Death
    Date Received
    June 15, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K842375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD/RESULTS: DEVICE HISTORY REVIEW NOT PERFORMED. NO PRODUCT HAS BEEN RETURNED, AND THE ACTUAL LOT NUMBER OF THE PRODUCT IS UNKNOWN. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: MEDTRONIC WAS INFORMED THAT THE PRODUCT WAS NOT AVAILABLE FOR RETURN. IN ADDITION, THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. CONCLUSION: BASED ON THE AVAILABLE INFORMATION, THE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL CANNULA ARE OBSERVED FOR INTEGRITY. IT IS UNKNOWN WHEN THE SPLIT IN THE CANNULA OCCURRED; HOWEVER, IT WAS SUSPECTED THAT IT OCCURRED POST-DISTRIBUTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING A PROCEDURE, A SPLIT WAS OBSERVED ON THE PROXIMAL END IN THE BODY OF THIS CANNULA AND THE WIRE WAS CRACKED. AS A RESULT, THE PATIENT RECEIVED AIR EMBOLI, AND EXPIRED 6 HOURS AFTER THE PROCEDURE IN POST-OPERATIVE CARE. THE OFFICIAL CAUSE OF DEATH WAS UNKNOWN AS NO AUTOPSY WAS PERFORMED. THE PRODUCT WAS NOT AVAILABLE FOR RETURN AS IT WAS BEING HELD IN RISK MANAGEMENT AT THE HOSPITAL, AND THE LOT NUMBER IS UNKNOWN.

    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 UNK Death