BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT

    MDR report key: 1982500 · Received February 1, 2011

    Report

    Report Number
    2184009-2011-00008
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    November 14, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DQY
    PMA / PMN Number
    K884129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED FOR ANALYSIS. ANALYSIS WAS LIMITED TO DEVICE HISTORY REVIEW. REVIEW OF MFG RECORDS FOR THIS PRODUCT DID NOT REVEAL ANY ABNORMALITIES OR NON-CONFORMANCES. CONCLUSION: THE INFO OBTAINED RELATED TO THIS EVENT SEEMS UNCLEAR. APPARENTLY THIS EVENT HAPPENED IN THE PEDIATRIC INTENSIVE CARE UNIT BY THE ECMO TEAM. BASED ON THE AVAILABLE INFO IT IS POSSIBLE THE DEVICE WAS USED FOR A PURPOSE BEYOND ITS INTENDED USE (INSERTED INTO OPEN VESSEL, ETC), THE PRODUCT WAS NOT USED PROPERLY, OR THERE WAS A MISUNDERSTANDING/MISCOMMUNICATION OF THE EVENT. BASED ON THE HISTORICAL PERFORMANCE OF THIS PRODUCT, IT WOULD BE EXTREMELY DIFFICULT TO INSERT THE STRAIGHTENER INTO A PT AND THEN LOSE THE GUIDEWIRE USED DURING THE PROCEDURE WITHIN THE PT. IN CONCLUSION: A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT DQY MEDTRONIC PERFUSION SYSTEMS 96530-015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1