BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FX25RE PRESCRIPTIVE OXY SUB

    MDR report key: 5078741 · Received September 15, 2015

    Report

    Report Number
    1124841-2015-00254
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    September 6, 2015
    Report Date
    October 30, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DTZ
    PMA / PMN Number
    K140774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO THE FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON SEPTEMBER 15, 2015. (B)(4). THE ACTUAL DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND NO ANOMALIES, INCLUDING A BREAK, WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE ACTUAL SAMPLE WAS RINSED AND DRIED AND THEN SUBJECTED TO THE FOLLOWING HEMATOLOGIC TESTING: BLOOD CONDITION: HB12.0 G/DL, TEMP.37OC., PH:7.4, SVO2:65% AND PVCO2:45MMHG CIRCULATION CONDITIONS: AT V/Q=1, FIO2=100% AND THE FLAW RATE OF 6L/MIN. AND 4 L/MIN. RESULT: S/N (B)(4): O2 ADDITION: @6 L/MIN.= 392ML/MIN. @4 L/MIN.= 286ML/MIN. CO2 REMOVAL: @6 L/MIN.=316ML/MIN. @4 L/MIN.= 232ML/MIN. S/N (B)(4): O2 ADDITION: @6 L/MIN.= 413ML/MIN. @4 L/MIN.= 295ML/MIN. CO2 REMOVAL: @6 L/MIN.= 321ML/MIN. @4 L/MIN.= 233ML/MIN. NO ANOMALIES WERE REVEALED IN THE GAS TRANSFER PERFORMANCE OF THE ACTUAL SAMPLE. IT WAS CONFIRMED THAT PRODUCT SPECIFICATIONS WERE MET. FURTHER, THE PERFUSION RECORD WAS REVIEWED AND IT REVEALED THE PATIENT DEMONSTRATED SIGNS OF HEPARIN RESISTANCE. DEVICE LABELING ADDRESSES THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS: START GAS SUPPLY WITH V/Q=1 AND FIO2=100%, THEN MAKE MEASUREMENTS BASED ON BLOOD GAS MEASUREMENTS. ADEQUATE HEPARINIZATION OF THE BLOOD IS REQUIRED TO PREVENT IT FROM CLOTTING IN THE SYSTEM. A PHENOMENON CALLED WET LUNG MAY OCCUR WHEN WATER CONDENSATION OCCURS INSIDE FIBERS OF MICROPOROUS MEMBRANE OXYGENATORS WITH BLOOD FLOWING EXTERIOR TO THE FIBERS. THIS MAY OCCUR WHEN OXYGENATORS ARE USED FOR A LONGER PERIOD OF TIME. IF WATER CONDENSATION AND/OR A DECREASE IN PAO2 AND/OR AN INCREASE IN PACO2 IS NOTED DURING EXTENDED OXYGENATOR USE, BRIEFLY INCREASING THE GAS FLOW RATE MAY IMPROVE THE PERFORMANCE. INCREASE GAS FLOW RATE, TO 20 L/MIN FOR 10 SECONDS. DO NOT REPEAT THIS FLUSHING TECHNIQUE, EVEN IF OXYGENATOR PERFORMANCE IS NOT IMPROVED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS. (B)(4). UPON COMPLETION OF THE INVESTIGATION, IT WAS FOUND THAT THE REVIEW OF THE DEVICE HISTORY RECORD HAD NOT BEEN INCLUDED IN THE FIRST FOLLOW-UP FOR THE DEVICE EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AND/OR MORE INFORMATION BECOMES AVAILABLE. FOR THIS REASON, EVALUATION CODE WAS REFERENCED. (B)(4). ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION OBTAINED FROM THE USER FACILITY INDICATED THAT THIS WAS AN EMERGENT, COMPLEX PROCEDURE AND THE PATIENT HAD OTHER CO-MORBID CONDITIONS SUCH AS RENAL FAILURE AND SHOWED SIGNS OF HEPARIN RESISTANCE. CPB LASTED OVER 5 HOURS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION, THAT DURING CARDIOPULMONARY BYPASS, THE PATIENT EXPERIENCED LOW PO2. THE DEVICE WAS CHANGED OUT TWICE (2) RESULTING IN APPROXIMATELY 250ML BLOOD LOSS AND A TOTAL DELAY TIME OF APPROXIMATELY 2 MINUTES. HOWEVER, IF WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A THIRD DEVICE. BLOOD LOSS OF APPROXIMATELY 250ML; DEVICE CHANGED OUT TWICE; PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608880 FX25RE PRESCRIPTIVE OXY SUB BLOOD GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP CXOT162 TG22

    Patients

    Seq Age Sex Outcome Treatment
    1 Other