Model Number 3CX*FX25REC |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 08/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was thrombus formation in the hardshell reservoir.Per facility, during bypass the perfusionist noticed thrombin forming in the hardshell reservoir.She then changed the reservoir out, not the oxy, and put a new hardshell reservoir in and the cases was finished with no other issues.Procedure: septal defect procedure - asd, tricuspid valve position - repair , there was a minute delay in the procedure, there was approximately 400 ml of blood loss, the product was changed out, the surgery was completed successfully, the patient is fine after the procedure.
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Manufacturer Narrative
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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 september 12, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10,3331,213 ,67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was inspected upon receipt with some clotting noted within the reservoir.It was set up for cr and vr defoaming testing.The cr defoaming test was set up and blood was flowed at 5 lpm with air introduced into the suction ports at approximately 100ml/min for one hour.The unit was observed for foaming at 15-minute intervals for 1 hour.There was no foaming observed.Next the vr defoaming test was set up and blood was flowed at 8 lpm with air introduced into the venous inlet at approximately 100ml/min for one hour.The unit was observed for foaming after the first 5 minutes and 60 minutes, which is the end of test.There was no foaming or clotting observed.The unit was found to function as intended; therefore, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Event Description
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Additional information as per the clinical specialist that, this complaint involved the reservoir of a fx25 oxygenator that had thrombin form on it approximately one hour into cardiopulmonary bypass.A pump record was provided that revealed adequate act values during the pump run and additional administrations of heparin.A hepcon value was taken prebypass that was adequate for bypass; however no other hepcon values were taken during bypass.From the information provided from the clinician, it appears that the patient either had some heparin resistance or something else going on that affected the ability to adequately anticoagulate the patient¿s blood.
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Search Alerts/Recalls
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