BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX OXYGENATOR W/HARDSHELL RESERVOIR

    MDR report key: 1941037 · Received December 8, 2010

    Report

    Report Number
    1124841-2010-00223
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K062381
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID RECEIVE THE ACTUAL DEVICE FOR EVAL. VISUAL INSPECTION CONFIRMED THAT THE WATER INLET PORT WAS DAMAGED. THE DAMAGE TO THE PORT IS CONSISTENT WITH AN EXTERNAL FORCE APPLIED DURING SHIPPING AND HANDLING. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS LOT. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THE WATER INLET PORT ON THE OXYGENATOR WAS DAMAGED. THERE WAS NO PT INVOLVEMENT. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    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 MK09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK