1 of 2 reports.Other mfg report number: 3013886523-2020-00025 a physician reported infection and cerebral spinal fluid retention: the certas valve was implanted with using bactiseal catheter(823072) via v-p shunt on (b)(6) 2020 with an unknown setting.However, on (b)(6) 2020, infection and csf retention under the skin were observed.The setting was changed to 1 but the csf flow could not be confirmed.Therefore, the valve will be replaced to a new one(competitor's one) on (b)(6) 2020.The physician confirmed that the setting could be changed and setting was 1 after the procedure.The protein concentration was 400 due to infection.
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Unique device identification (udi) : (b)(4).The certas valve was returned for evaluation.Device history record was not possible as the lot number was unknown.Failure analysis - the valve was visually inspected; a needle hole in the needle chamber was noted.The valve passed the test for programming, reflux, siphon guard and pressure.The valve was leak tested, only leaked form the needle hole in the needle chamber.No root cause could be determined as the technician was unable to confirm the problem reported by the customer.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up this could interfere with the device, but at the time of investigation no issues were noted.
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