Haemonetics sent a field service engineer to evaluate the cell saver® elite® autotransfusion system, it was determined that there was no detected problem with the system.Customer stated that the bowl was inspected and no visible cracks were observed.Although no cracks were determined by customer, haemonetics did not receive the sample back for evaluation to determine cause.
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On may 04, 2021 haemonetics was notified of a long hour returning error which was observed during a vascular procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 125ml.During the procedure it was also noted that there were prior error messages of pressure in blue line and fluid detected early.There was 293mls of blood was lost, and patient did require a post-operative transfusion.Customer stated there were unable to provide current patient health status due to confidentiality.
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