BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTOPUS PERFUSION SET

    MDR report key: 1941611 · Received December 20, 2010

    Report

    Report Number
    1941611
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 20, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    MWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT END OF THE CASE, THE SURGEON NOTED THAT THERE WAS A SLIGHT BACKFLOW OF BLOOD AND CARDIOPLEGIA IN ONE OF THE MULTI PORT PERFUSION CANNULA USED DURING BYPASS SURGERY. THERE WAS A SLIGHT LEAKAGE NOTED TO THE BASE OF THE CANNULA WHERE THE RN NOTED A SMALL CRACK/HAIRLINE TYPE FRACTURE TO THE TUBING. THERE WAS NO ADVERSE OUTCOME OR EFFECT TO THE PATIENT. THE PATIENT WAS SUCCESSFULLY WEANED FROM BYPASS AND TRANSFERRED TO THE CVCU FOR RECOVERY. THE FACILITY CONSIDERS THIS EVENT TO BE AN OUT-OF-BOX FAILURE. THERE WAS NO MENTION OF ANY MANIPULATING, CUTTING, OR PUNCTURING THE DEVICE WHICH COULD HAVE EXPLAINED THE CRACK IN THE TUBING. IT IS BELIEVED THAT THIS CRACK WAS PRESENT UPON USE, BUT NOT IDENTIFIED UNTIL CLOSE TO THE END OF THE SURGICAL CASE WHEN OOZING OF BLOOD WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTOPUS PERFUSION SET MEDTRONIC OCTOPUS MULTIPLE PERFUSION SET MWS MEDTRONIC * 2010070859

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR CARDIAC DRUGS| NONE NOTED