BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPIOX RX OXYGENATOR W/HARDSHELL RESERVOIR

    MDR report key: 1918147 · Received December 3, 2010

    Report

    Report Number
    1124841-2010-00220
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE. THIS ISSUE HAS BEEN DETERMINED TO BE A CUSTOMER PREFERENCE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, OUT OF BOX, THE PLACEMENT OF THE GREEN PROTECTIVE CAP ON THE OXYGENATOR IS CONFUSING. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO DELAY TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX RX OXYGENATOR W/HARDSHELL RESERVOIR BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK