This initial mdr is being submitted as a result of a retrospective review of davol's mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.It was reported to davol that during a procedure the suretrans device was place during a knee arthroplasty and within less than 2 hours postoperatively while still in the pacu, the patient's blood began to clot in the drain and collection container.The device was switched to hemovac, with no patient injury reported.The subject product was not returned for evaluation.To ensure proper blood flow during collection and reinfusion, it is advised to routinely check the tubing for patency and make sure that the clamps are open.It was cautioned, that although the system will function without regulated suction, suction regulators (set at -80 to -100 mmhg) are always recommended.At that point it was unclear why the patient's blood clotted in the drain and collection container, root cause was undetermined.Device not returned.
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