Patient identifier: requested, unknown.Date of birth: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k071494, k130520.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.(b)(4).
|
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual inspection of the actual sample found that the blood inlet port had been fractured at the root.The housing of the blood inlet port side was removed, then the area around the root of the blood inlet port was inspected under a magnifier.No crack, no deformity, or no other external anomaly was observed around the root of the blood inlet port.The fracture surface was inspected under a magnifier and found smooth over the entire area.A rippled pattern was observed between the front side and bottom side of the oxygenator, with a streaky pattern extending from it.From this, it was inferred that shock force was applied to the blood inlet port from the direction between the front side and bottom side of the oxygenator.As a result, the fracture extended starting from the center of the rippled pattern in the direction of the streaky pattern.Based on the investigation result, it was likely that the blood inlet port was subjected to a shock force from the direction between the front side and the bottom side of the oxygenator, resulting in the fracture.Since no anomaly was noted in the manufacturing-related records, it was presumed that the actual sample was subjected to shock force accidentally at some point during transportation or storage.From the available information including the state of the actual sample, however, the specific timing could not be determined.Relevant ifu reference: if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution).
|