Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the product-release judgement record of the involved product/lot# combination confirmed there was no anomaly in them.Regarding the involved product code/lot# combination, no similar report from other facilities was confirmed in the complaint records; however, there is one similar report from the same facility, which is under the investigation as the actual sample for analysis has not yet been received.Ifu states: "do not use an oxygenator that leaks." according to the results of the investigation, no anomaly was found in the manufacturing record and the product-release judgement record.The actual sample was not available for analysis, in addition, the occurrence situation in details such as the exact leak point and leakage status was unknown; the cause of occurrence could not be clarified.(b)(4).
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