BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/HR C COATING

    MDR report key: 3205535 · Received July 1, 2013

    Report

    Report Number
    1124841-2013-00135
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTN
    PMA / PMN Number
    K002238
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE OXYGENATOR LEAKED FROM SCAVENGER PORT. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297698 SX OXYGENATOR W/HR C COATING BLOOD-GAS OXYGENATOR DTN TERUMO CARDIOVASCULAR SYSTEMS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR