BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR

    MDR report key: 2001777 · Received February 21, 2011

    Report

    Report Number
    1124841-2011-00046
    Event Type
    Other
    Date Received
    February 21, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CARDIOVASCULAR SYSTEMS DID NOT RECEIVE THE ACTUAL DEVICE; HOWEVER, AN INVESTIGATION WAS CONDUCTED ON A RETENTION SAMPLE AND NO DAMGE WAS NOTED. THE MOST LIKELY SOURCE OF THE CRACK ON THE RESERVOIR IS EXCESSIVE EXTERNAL FORCE APPLIED TO THE UNIT DURING SHIPPING AND HANDLING POST MFG, THUS REFERENCED EVAL CODES. (B)(4). A REVIEW OF THE COMPLAINT FILES COULD NOT CONFIRM THAT THERE HAVE BEEN PREVIOUS REPORTS FOR THIS LOT. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MGMT FOR APPROPRIATE TRACKING, TRENDING, AND F/U.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SET-UP, THERE WAS A CRACK ON TOP OF THE RESERVOIR BY THE VENOUS INLET. THERE WAS NO PT INVOLVEMENT AS THIS OCCURRED DURING SET-UP. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX SX OXYGENATOR W/ HARDSHELL RESERVOIR BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA MM04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK