BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 3418483 · Received October 18, 2013

    Report

    Report Number
    9681834-2013-00128
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 19, 2013
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED TO TERUMO FOR EVALUATION; THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED. A RETENTION SAMPLE WAS EVALUATED FOR APPEARANCE, PRESSURE LOSS (WITH BOVINE BLOOD), LEAKAGE (WITH NORMAL SALINE), GAS LINE PRESSURE LOSS AND AIR INJECTION INTO A MODEL CIRCUIT. NO ABNORMALITIES WERE FOUND, AND THE RETENTION SAMPLE OPERATED WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE INVOLVED PRODUCT/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NO INDICATIONS OF PRODUCTION-RELATED ANOMALIES. THE IFU STATES: 'WHEN THE LEVEL OF BLOOD IN THE RESERVOIR IS BELOW THE MINIMUM OPERATING LEVEL, BLOOD FLOW AT A HIGH FLOW RATE INTO THE CARDIOTOMY FILTER MAY GENERATE GASEOUS MICRO EMBOLI (GME) WHICH COULD MIGRATE TO THE PATIENT.' 'MINIMUM OPERATING VOLUME IN R40 RESERVOIR IS 200 ML AND 70 ML IN R30 RESERVOIR,' AND 'WHEN LEVEL ALARM SYSTEM IS USED, SET THE SENSOR AT THE POSITION BETWEEN 70 ML - 400 ML OF R30 RESERVOIR.' FURTHER INFORMATION IS PENDING. A FOLLOW-UP REPORT SHALL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4). METHOD: DEVICE FROM RESERVE SAMPLE EVALUATED. PERFORMANCE TESTS PERFORMED. RESULTS: NO FAILURE DETECTED. CONCLUSIONS: CONCLUSION NOT YET AVAILABLE - EVALUATION IN PROGRESS. OFF LABEL, UNAPPROVED, OR CONTRAINDICATED USE. 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 MEDICAL CORPORATION IN THE INITIAL REPORT SUBMITTED TO THE FDA ON OCTOBER 18, 2013. THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: (DEVICE AVAILABLE FOR EVALUATION), (INDICATION THAT THIS IS A FOLLOW-UP REPORT), (DATE RECEIVED BY MANUFACTURER), (FOLLOW-UP REPORT IS DUE TO ADDITIONAL INFORMATION AND DEVICE EVALUATION), (DEVICE EVALUATED BY MANUFACTURER), (B)(4). A VISUAL INSPECTION OF THE ACTUAL SAMPLE CONFIRMED NO ANOMALIES IN THE APPEARANCE OF THE DEVICE. THE RETURNED SAMPLE WAS PRESSURE TESTED USING SALINE SOLUTION. THE BLOOD OUTLET PORT WAS CLAMPED, AND PRESSURE WAS APPLIED FROM THE BLOOD INLET PORT SIDE. NO LEAK WAS OBSERVED. PRESSURE DROP IN THE GAS PATHWAY WAS ALSO MEASURED USING SALINE SOLUTION AND AIR, AND THE OBTAINED VALUES WERE WITHIN PERFORMANCE SPECIFICATIONS. THE OXYGENATOR WAS THEN CIRCULATED WITH BOVINE BLOOD TO DETERMINE PRESSURE DROP OF THE BLOOD PATHWAY AT EACH FLOW RATE. ALL OBTAINED VALUES MET PERFORMANCE SPECIFICATIONS. THE SAMPLE WAS BUILT INTO A CIRCUIT WITH TUBING, CENTRIFUGAL PUMP AND AN ARTERIAL FILTER. BOVINE BLOOD WAS CIRCULATED AT BLOOD FLOW RATES OF 1.7, 3.4, AND 5.0 L/MIN, WITH A BACK PRESSURE OF 200 MMHG. DURING CIRCULATION, 30 ML OF AIR WAS INJECTED INTO THE CIRCULATION BETWEEN THE OXYGENATOR AND THE CENTRIFUGAL PUMP. AFTER FIVE MINUTES, THE ARTERIAL FILTER WAS INSPECTED FOR AIR ENTRAINMENT, AND NONE WAS OBSERVED. A VISUAL INSPECTION OF THE RESERVOIR DID NOT REVEAL ANY ANOMALIES. THE RESERVOIR WAS DISASSEMBLED FOR FURTHER INSPECTION OF THE FILTERS AND WALL THICKNESS OF THE RESERVOIR HOUSING. THE RESERVOIR WAS CONFIRMED TO BE WITHIN PRODUCT SPECIFICATIONS. ALL INVESTIGATION RESULTS CONFIRMED THAT THE ACTUAL SAMPLE WAS WITHIN PRODUCT SPECIFICATIONS; THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED. METHOD CODE: ACTUAL DEVICE EVALUATED, PERFORMANCE TESTS PERFORMED, PRESSURE TESTING. RESULTS CODE: NO FAILURE DETECTED. CONCLUSIONS CODE: NO FAILURE DETECTED, DEVICE OPERATED WITHIN SPECIFICATION. ALL AVAILABLE INFORMATION 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 CORPORATION THAT IN THE FINAL STAGE OF A CARDIAC VALVE SURGERY, A GASEOUS EMBOLISM WAS NOTED IN THE ARTERIAL LINE. EXTRACORPOREAL CIRCULATION (ECC) WAS STOPPED, AND DE-AIRING OF THE ARTERIAL LINE WAS PERFORMED. THE INCIDENT OCCURRED AT THE END OF THE SURGERY WHEN THE PERFUSIONIST CLAMPED THE VEIN AND ATTEMPTED BLOOD FLOW INTO THE HEART. THE PERFUSIONIST NOTED THAT THE MEMBRANE DRAINED QUICKLY AND THE LEVEL OF BLOOD IN THE RESERVOIR DECREASED SUDDENLY. THE HEART LUNG MACHINE SENSORS DID NOT ALARM FOLLOWING THE INTRODUCTION OF AIR AFTER THE CIRCUIT WAS DRAINED. IT WAS NOTED BY THE CUSTOMER THAT THE LEVEL SENSOR FOR THE HEART LUNG MACHINE WAS ATTACHED AT THE BACK OF RESERVOIR, FIXED SLIGHTLY UNDER THE LIMIT OF THE MINIMUM LIMIT OF THE RESERVOIR, AS THE END-USER HAD DIFFICULTY ATTACHING IT TO THE FRONT OF THE RESERVOIR. TO MITIGATE THE POSSIBILITY OF INTRODUCING AIR TO THE PATIENT, RETROGRADE PERFUSION THROUGH THE SUPERIOR VENA CAVA WAS PERFORMED. POST OPERATIVE TREATMENT IN A HYPERBARIC CHAMBER WAS PERFORMED AS A PRECAUTIONARY MEASURE TO FURTHER MITIGATE THE POTENTIAL FOR ANY POSSIBLE AIR EXPOSURE TO THE PATIENT. FOLLOW-UP CONDITION WAS CONDUCTED ON (B)(6) 2013, AND THE PATIENT WAS STABLE WITH NO REPORTS OF NEUROLOGICAL EFFECTS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2013-00128 TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY AND THE RESULTS OF THE EVALUATION OF THE RETURNED SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535268 CAPIOX FX OXYGENATOR BLOOD GAS OXYGENATOR DTZ TERUMO CORPORATION, ASHITAKA 1ZZ*FX15RW30 121022

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention ECC MACHINE (ALARM) SORIN S5