BEUDAMED
    FDA Adverse Event Injury Summary report: N

    560 BIO-CONSOLE BASE UNIT

    MDR report key: 2132143 · Received June 10, 2011

    Report

    Report Number
    2184009-2011-00035
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K070286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: REVIEW OF DEVICE EVENT LOG WAS CONDUCTED. ANALYSIS: A REVIEW OF THE BIOCONSOLE EVENT LOG WAS CONDUCTED AND COULD NOT CONFIRM THAT THE LOW LEVEL SENSOR ALARM WAS SET TO STOP WHEN AIR WAS DETECTED (INDICATING THE LEVEL IS LOW). BASED ON THE CLINICAL OBSERVATION AND INVESTIGATION, A DISCUSSION TOOK PLACE WITH THE HEALTHCARE PROFESSIONAL WHERE IT WAS DETERMINED THAT OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED TO DISTRIBUTION. CONCLUSION: BASED ON THE CLINICAL OBSERVATION AND INVESTIGATION, OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT. THE PT'S DEATH WAS NOT ATTRIBUTED TO THE DEVICE.

    Description of Event or Problem · 1

    MEDTRONIC REC'D INFORMATION THAT DURING THIS BYPASS PROCEDURE, THE LEVEL SENSOR WAS USED BUT THE AUTO CLAMP WAS NOT TURNED ON; THE UPPER LEVEL WAS SET TO ALARM AND THE LOWER SENSOR WAS SET TO STOP. AS A RESULT OF THE LOWER LEVEL SENSOR SETTING, THE BIOCONSOLE STOPPED FIVE (5) HOURS INTO THE BYPASS PROCEDURE FOR APPROX ONE (1) MINUTE. IT WAS REPORTED THAT THE BIOCONSOLE WAS THEN OPERATED BY USE OF THE HAND CRANK FOR TWO (2) MINUTES UNTIL THE BIOCONSOLE WAS RE-STARTED. IT WAS ALSO REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THE PT DIED DUE TO REASONS NOT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 560 BIO-CONSOLE BASE UNIT DWA MEDTRONIC PERFUSION SYSTEMS 560B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention