BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SX OXYGENATOR W/ HR X COATING

    MDR report key: 6156632 · Received December 8, 2016

    Report

    Report Number
    1124841-2016-00425
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 17, 2016
    Report Date
    February 8, 2017
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K153140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE 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 WHEN MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON. (B)(4). RESULTS - RESULTS PENDING COMPLETION OF EVALUATION. CONCLUSIONS - CONCLUSION NOT YET AVAILABLE-EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON DECEMBER 8, 2016. (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED, DURING WHICH NO ANOMALIES WERE NOTED. DURING THE DECONTAMINATION PROCESS, BLEACH SOLUTION AND WATER WERE CIRCULATED THROUGH THE DEVICE. IT WAS FOUND THAT THE FLUID LEAKED THROUGH THE GAS PORTS DURING THIS CIRCULATION. NO PRESSURE WAS APPLIED TO THE DEVICE DURING THIS CIRCULATION. IT WAS FOUND THAT THERE WAS A LEAK IN THE PIPES OF THE HEAT EXCHANGER. A RETENTION SAMPLE FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION WAS OBTAINED FOR EVALUATION. VISUAL INSPECTION FOUND NO ANOMALIES ON THE RETENTION SAMPLE. THE BLOOD SIDE OF THE UNIT WAS THEN FILLED WITH WATER AND PRESSURIZED TO APPROXIMATELY 650 MMHG. NO LEAKS WERE NOTED FROM ANYWHERE ON THE DEVICE, SPECIFICALLY THROUGH THE GAS PORTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO MANUFACTURING ANOMALIES. ALL HEAT EXCHANGERS ARE LEAK TESTED IN PROCESS; THEREFORE, IT IS LIKELY THAT DAMAGE OCCURRED TO THE DEVICE AT SOME POINT AFTER MANUFACTURE THAT CAUSED A PIPE(S) IN THE HEAT EXCHANGER TO LEAK. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TERUMO CARDIOVASCULAR THAT DURING PRE CARDIOPULMONARY BYPASS, THE OXYGENATOR WAS NOT HOLDING PRESSURE. THERE WAS NO PATIENT INVOLVEMENT. PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806637 SX OXYGENATOR W/ HR X COATING BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CXSX25R UK22

    Patients

    Seq Age Sex Outcome Treatment
    1