Model Number ICF100 |
Device Problems
Failure to Zero (1683); Inaccurate Information (4051)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 02/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device was returned to edwards for evaluation.Evaluation is in progress.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.
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Event Description
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Edwards received information that during inflation of a vascular clamp, the aortic root pressure, even with root vent running, did not drop to zero or negative with expected fill volume.It dropped from approximately 65 to 25 with 30 ml of volume and an internal balloon pressure of 390 mmhg.Perfusion also was not getting any blood back to pump from vent at this point.Antegrade cardioplegia was delivered, patient had a quick arrest and retrograde cardioplegia was delivered throughout the case (approximately 50 ml as the patient had prior cabg with patent mammaries).Throughout the case, aortic root never got to zero and always stayed approximately 25 even with periodic running of aortic vent to clear retrograde cpb through coronaries.The rest of the case was uneventful.
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Manufacturer Narrative
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Device evaluation: customer report of pressure reading issues was unable to be confirmed.No pressure monitoring devices were returned with product.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the catheter was still attached to a cannula.The shaft was kinked where the cannula was attached to it.The catheter shaft was also kinked near the hub.As received, the ao root pressure lumen was occluded with blood.All other through lumens were found to be patent without any leakage or occlusion.Catheter balloon inflated clear and remained inflated for more than 5 min.Without leakage.No other visual damage, contamination, or other abnormalities were found.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Manufacturer Narrative
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Reference capa-20-00141.
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Search Alerts/Recalls
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