BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SX OXYGENATOR W/ HR X COATING

    MDR report key: 4973705 · Received August 5, 2015

    Report

    Report Number
    1124841-2015-00218
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    March 25, 2015
    Report Date
    October 21, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K130359
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REJECT MFR #1124841-2015-00262 DUE TO THE REPORTING ERROR AS AN INITIAL REPORT. ON OCTOBER 6, 2015, THE MANUFACTURER BECAME AWARE THAT MEDWATCH #(B)(4) WAS SUBMITTED AS AN INITIAL REPORT RATHER THAN A FOLLOW-UP RESULTING IN THE ASSIGNMENT OF A NEW MFR REPORT NUMBER (1124841-2015-00262). THE INFORMATION SHOULD HAVE BEEN REPORTED AS A FOLLOW-UP FOR MFR #1124841-2015-00218.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION SO A RETENTION SAMPLE WAS EVALUATED. IT WAS SUBJECTED TO LEAK TESTING AT 1.5 KG/CM2 FOR 10 MINUTES. NO LEAKS WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THERE WERE NO ANOMALIES. BASED ON THE INVESTIGATION FINDINGS AND ADDITIONAL INFORMATION OBTAINED FROM THE USER FACILITY, THIS COMPLAINT WAS NOT CONFIRMED AND HAS BEEN ATTRIBUTED TO CUSTOMER TECHNIQUE. 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.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT DURING EXTRACORPOREAL CIRCULATION (ECC), THE PERFUSIONIST NOTICED "VERY SMALL QUANTITIES" OF BLOOD LOSS. IT WAS ALSO NOTED THAT NO DEFICIT OF OXYGENATION CAPACITY OCCURED WITH THE DEVICE. SUBSEQUENTLY, THE PERFUSIONIST CHANGED OUT THE OXYGENATOR RESULTING IN 350 ML OF BLOOD LOSS. REPORTEDLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    ON 9/22/2015, IT WAS REPORTED BY THE MANUFACTURER TO THE FDA THAT ADDITIONAL INFORMATION OBTAINED FROM THE USER FACILITY INDICATED THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 3 MINUTES TO CHANGE OUT THE OXYGENATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE USER FACILITY REPORTED THAT A 1 CM CRACK WAS NOTED FROM THE BLOOD OUTLET PORT AND THE PVC TUBE. REPORTEDLY, IT OCCURRED WHEN THE DEVICES WERE CONNECTED AND CAUSED BY HIGH PRESSURE. FURTHER INFORMATION PROVIDED BY THE USER FACILITY INDICATED THAT THE EVENT RESULTED IN NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512573 SX OXYGENATOR W/ HR X COATING BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS 3CXSX25RX RL22

    Patients

    Seq Age Sex Outcome Treatment
    1 Other