Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed no break or no other obvious anomaly that could have contributed to the decrease in platelet.The actual sample, after rinsed with normal saline poured by gravity drop, was subjected to visual inspection.As a result, blood clots were found to have been formed in the bottom side; however, it was not determined whether they were formed during the use or the return shipment to the factory.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.The exact cause of the reported event cannot be definitively determined based on the available information.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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The user facility reported that the involved capiox custom pack was used during the procedure.Platelet count decreased markedly after pump started.Patient: bsa 0.2.Asd creation surgery.Act 480 sec.Pump time: 25 minutes.Platelet count: 135000/ microliter (pre-pump), 31000/ microliter (in 10 minutes), 23000/ microliter (off-pump).The procedure was completed successfully.The patient was not harmed.
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