BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/ HR X COATING

    MDR report key: 3862932 · Received February 20, 2014

    Report

    Report Number
    1124841-2014-00018
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 30, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED COUPLER PORTS WERE VISUALLY INSPECTED, AND NO ANOMALIES WERE OBSERVED. THE PORTS WERE MEASURED WITH A DIGITAL CALIPER AND FOUND TO BE WITHIN SPEC. THE RETURNED COUPLER PORTS WERE CONNECTED TO THE RETURNED CONNECT FITTING. ALTHOUGH THE CONNECTION WAS MORE DIFFICULT THAT NORMAL, THE RETURNED PARTS WERE SUCCESSFULLY PAIRED. THE RETURNED PORTS WERE THEN CONNECTED TO A FACTORY RETAINED QUICK CONNECT FITTING, AND THE CONNECTION WAS EASILY MADE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO INDICATION OF PRODUCTION RELATED ANOMALIES. THE RETURNED WATER PORTS WERE DETERMINED TO BE WITHIN SPEC; THEREFORE, THIS EVENT WAS NOT CONFIRMED. (B)(4). ALL AVAILABLE INFO HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE WATERLINE CONNECTION OF THE OXYGENATOR WOULD NOT CONNECT TO THE QUICK DISCONNECT. THE CUSTOMER WAS EVENTUALLY ABLE TO MAKE THE CONNECTION. NO PT IMPACT AS THIS EVENT OCCURRED DURING SETUP. PRODUCT WAS NOT CHANGED OUT. SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106859 SX OXYGENATOR W/ HR X COATING BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CXSX18RX QN25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK