Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510k # - k130280.The actual sample was not available for investigation.Since the actual sample was not returned to ashitaka factory, the investigation of it was unable to be performed.However, the image of the actual sample showed that the sampling system had been detached from the mount.Review of the manufacturing record and the product-release judgment record of the involved product/lot# combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.Ifu states: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." based on the investigation and our experience, as a possible cause of occurrence, it was inferred that they attempted to detach the mount from the reservoir in a way grabbing the sampling system only.Since the actual sample was not returned for analysis, the cause of occurrence could not be clarified.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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