BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVASCULAR PROCEDURE KIT

    MDR report key: 1874376 · Received October 12, 2010

    Report

    Report Number
    1212122-2010-00188
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 17, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    OEZ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO DID NOT RECEIVE THE ACTUAL DEVICE, THEREFORE NO PHYSICAL INVESTIGATION WAS PERFORMED. NO SAMPLE WILL BE RECEIVED. SINCE NO LOT NUMBER WAS PROVIDED, TERUMO IS UNABLE TO DETERMINE INFO ON THE SEAL. IT IS UNCLEAR AS TO WHEN THE SEAL BREACHED, THEREFORE, THE ROOT CAUSE OF THIS COMPLAINT IS UNK. TERUMO WILL MONITOR FOR FUTURE ISSUES. THE COMPLAINT WILL BE INCLUDED IN ASSOCIATE AWARENESS TRAINING. NO LOT NUMBER WAS PROVIDED; NO DHR REVIEW WAS PERFORMED. ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND F/U. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, OUT-OF-BOX, THE PEEL POUCH WAS NOT COMPLETELY SEALED. THERE WAS NO HARM TO THE PT AS THIS OCCURRED OUT-OF-BOX. THE EVENT DID NOT RESULT IN DELAY IN SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR PROCEDURE KIT CONVENIENCE TUBING PACK OEZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK