BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPIOX SX18 OXYGENATOR

    MDR report key: 596850 · Received April 28, 2005

    Report

    Report Number
    1124841-2005-00009
    Event Type
    Other
    Date Received
    April 28, 2005
    Date of Event
    March 20, 2003
    Report Date
    March 31, 2005
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN 03/2005, A LEGAL SUMMONS AND OCMPLAINT WAS RECEIVED ALLEGING THAT AN ADVERSE EVENT HAD OCCURRED DURING BYPASS SURGERY IN 2003. THE COMPLAINT (ALSO ISSUED TO ATTENDING PHYSICIANS, THE HOSP, VARIOUS MEDICAL SERVICES, ET AL.), GENERALLY ALLEGES THAT AN OXYGENATOR FAILED TO PROVIDE PROPER OXYGENATION TO THE PT DURING SURGERY. NO SPECIFICS OF ANY KIND WITH REGARD TO THE CO'S PRODUCTS HAVE BEEN ALLEGED. THE COMPLAINT FURTHER ALLGES THAT THE PT SUFFERED INJURIES RESULTING FROM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX18 OXYGENATOR OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA CM28A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other