BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPIOX FX OXYGENATOR W/ HARDSHELL RESERVOIR

    MDR report key: 2571568 · Received May 28, 2010

    Report

    Report Number
    9681834-2010-00045
    Event Type
    Other
    Date Received
    May 28, 2010
    Report Date
    May 6, 2010
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO IS STILL INVESTIGATING THIS ISSUE AND WILL BE SUBMITTING A FOLLOW-UP REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AFTER CARDIOPULMONARY BYPASS PROCEDURE THE PACKAGING FOR TERUMO'S RX AND FX OXYGENATORS ARE SIMILAR AND AS A RESULT THE INCORRECT OXYGENATOR WAS PULLED OFF THE SHELF. THE USER FACILITY REPORTED THAT THERE WERE NO COMPLICATIONS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX FX OXYGENATOR W/ HARDSHELL RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CORP, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK