BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODUCT OR MODEL UNKNOWN

    MDR report key: 1591246 · Received January 26, 2010

    Report

    Report Number
    2135394-2010-00003
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    December 28, 2009
    Report Date
    December 28, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    FZP
    PMA / PMN Number
    K031623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION: DEVICE HISTORY REVIEWED HAS NOT BEEN COMPLETED YET, AND NO PRODUCT HAS BEEN RETURNED. RESULT: DEVICE HISTORY REVIEWED HAS NOT BEEN COMPLETED YET AND NO PRODUCT HAS BEEN RETURNED. ANALYSIS: THIS DEVICE HAS NOT BEEN RETURNED FOR LABORATORY ANALYSIS. SHOULD ADD'L INFO BE PROVIDED, THIS EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT FILED. CONCLUSION: WITH THE AVAILABLE INFO, A CAUSE FOR THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFO THAT THIS U-CLIP CARTRIDGE BROKE WHEN THE REUSABLE DELIVERY DEVICE (UDD5) WAS BEING WITHDRAWN THROUGH THE ROBOT PORT THROUGH WHICH IT WAS INSERTED. A SMALL PIECE OF PLASTIC BROKE OFF AND COULD NOT BE FOUND. THE ROBOT PROCEDURE TURNED INTO AN OPEN CHEST SURGERY, AND THE PLASTIC WAS RETRIEVED BY THE PHYSICIAN. AT THE SAME TIME, A SCRUB NURSE WAS PREPARING A SECOND U-CLIP CARTRIDGE, AND THAT ONE BROKE WHILE TRYING TO ATTACH THE CARTRIDGE TO THE UDD5 OUTSIDE OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRODUCT OR MODEL UNKNOWN FZP MEDTRONIC PERFUSION SYSTEMS S18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R