(b)(4).Udi - not yet required for this product code/lot number combination, however the di portion was provided.The actual device has not been returned to the manufacturing facility.However, a photograph of the involved device was returned for evaluation.Therefore, the investigation was based upon evaluation of user facility information, a photograph of the involved device and a retention sample of the involved product code/lot# combination.The returned photograph of the actual device revealed the adhesion of clots inside the oxygenator module and on the rib set inside the venous filter.Visual inspection of the retention sample revealed no defects.The retention sample was built into a circuit with tubes and bovine blood was circulated through it.The pressure drop was determined at each specified flow rate.The obtained values were verified to meet manufacturing specification.No obstruction was observed inside the oxygenator module.Bovine blood was then circulated for 6 hours and no obstruction was observed inside the oxygenator module.The bovine blood was rinsed out of the retention sample and was subjected to another visual inspection.No obstruction was observed inside the oxygenator module.The actual device has not been returned to the manufacturing facility for evaluation and the investigation is still on going.For this reason, (b)(4).A follow up report will be submitted within 30 days of this report being sent.A review of the device history record and product release decision control sheet of the involved product/lot# combinations was conducted with no relevant findings.A search of the complaint file found no report with the presumed product code/lot# combinations.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
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