BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/ X COATING

    MDR report key: 5474773 · Received March 2, 2016

    Report

    Report Number
    1124841-2016-00087
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    January 25, 2016
    Report Date
    April 5, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    DTZ
    PMA / PMN Number
    K993772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE SAMPLE FOR AN IDENTICAL COMPLAINT, REPORTED IN MFR # 1124841-2016-00086, WAS RETURNED AND USED FOR THIS EVALUATION. THE PIGTAIL WAS FOUND TO BE UNATTACHED TO THE OXYGENATOR ON THIS SAMPLE. THE PORTION OF THE TUBING THAT HAD BEEN BONDED WITHIN THE PORT REMAINED INSIDE THE PORT, WHILE THE REST OF THE LINE APPEARED TO BE RIPPED FROM THE PORT. THE CUT IN THE TUBING WAS NOT CLEAN, AS THERE WERE ROUGH EDGES ON THE CROSS SECTION OF THE TUBING. IT APPEARED AS THOUGH THE TUBING WAS DAMAGED AT THE PORT AND TORN APART. A RETENTION SAMPLE FROM PRODUCT CODE 3ZZ*SX18RX LOT TH13 WAS VISUALLY INSPECTED AND THE PIGTAIL WAS INTACT WITH NO ANOMALIES. ALL UNITS ARE 100% VISUALLY INSPECTED IN PROCESS; THEREFORE, THE TUBING WAS INTACT DURING FINAL RELEASE OF THE PRODUCT. IT IS LIKELY THAT THE TUBING WAS DAMAGED BY A SHOCK FORCE, AS THE BONDED PORTION OF THE TUBING REMAINED INSIDE THE PORT AND THE CROSS SECTION OF THE TUBING HAD A ROUGH SURFACE; HOWEVER, IT IS UNKNOWN AS TO HOW OR WHEN THE TUBING WAS DAMAGED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SETUP, THE QUICK DISCONNECT TUBING DISCONNECTED FROM THE BLOOD OUTLET PORT OF THE OXYGENATOR. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS CHANGED OUT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130797 SX OXYGENATOR W/ X COATING BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 3CXSX18X TH13

    Patients

    Seq Age Sex Outcome Treatment
    1