BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX SX OXYGENATOR

    MDR report key: 2903777 · Received January 4, 2013

    Report

    Report Number
    1124841-2013-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 18, 2012
    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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A F/U REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET UP, THE MANIFOLD WAS CRACKED. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SET UP. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5057 CAPIOX SX OXYGENATOR BLOOD-GAS OXYGENATOR DTN TERUMO CARDIOVASCULAR SYSTEMS CORP. NA NP12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK