BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX SX OXYGENATOR

    MDR report key: 2903764 · Received January 4, 2013

    Report

    Report Number
    1124841-2013-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR INVESTIGATION. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED 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 SET-UP, A CRACK WAS NOTICED ON THE HEAT EXCHANGER. NO PT INVOLVEMENT AS THIS OCCURRED DURING SET-UP. PRODUCT WAS CHANGED OUT. SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5248 CAPIOX SX OXYGENATOR BLOOD-GAS OXYGENATOR DTN TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*SX25R PG04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK