BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/ HR X COATING

    MDR report key: 3862931 · Received February 20, 2014

    Report

    Report Number
    1124841-2014-00019
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 31, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K130359
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION CONFIRMED THAT THE CAP ON THE BLUE STOPCOCK HAD CRACKED OFF. NO OTHER DAMAGE WAS SEEN ON THE UNIT, INDICATING THAT THE DAMAGE WAS NOT CAUSED BY THE UNIT BEING DROPPED. THE ORIGINAL BOX AND STERILE BAG WERE NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO PRODUCTION RELATED ANOMALIES. A RETENTION SAMPLE FROM 3CXSX25RX/QM14 WAS INSPECTED. NO ANOMALIES WERE FOUND IN THE PACKAGING. ALL CAPS WERE INTACT AND PRESENT ON THE RESERVOIR AND SAMPLING MANIFOLD. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITHOUT THE ORIGINAL PACKAGING; HOWEVER, THE EVENT IS CONFIRMED DUE TO THE NOTED DAMAGE.(B)(4). ALL AVAILABLE INFO HAS BEEN PLACED IN (B)(4) FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOPULMONARY SYSTEMS CORP THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, OUT OF BOX, THE LUER LOCK CAP WAS BROKEN OFF THE SAMPLE PORT. NO PT INVOLVEMENT AS THIS OCCURRED OUT OF BOX. PRODUCT WAS NOT USED. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106781 SX OXYGENATOR W/ HR X COATING BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*SX25RX QM14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK