A physician reported no flow of a certas valve: the valve was implanted via l-p shunt in 2020 with unknown setting to treat subarachnoid hemorrhage.After implantation (unknown date) the patient presented with chronic hematoma; therefore, the valve was changed to vo.In (b)(6) 2020, as the patient's status improved, the setting was changed to 6 from 7.In (b)(6) 2020, the patient started with walking difficulty.When pumping the reservoir, it was slow to back and there was no flow to the peritoneal side when contrast agent was added.The valve was replaced on (b)(6) 2020.The patient also developed infection, treated with antibiotics.
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Unique device identifier (udi)- (b)(4).The certas valve was returned for evaluation: device history record (dhr)- review of records for the valve was not possible as the lot number and was unknown.Failure analysis- the valve was visually inspected, needle hole in the needle chamber was noted.The valve passed thetest for programming, flushing, reflux, siphon guard and pressure.The vlave was leak tested and only leaked from the needle hole in the needle chamber.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.No root cause could be determined for the infection reported by the customer as the lot number was unknown.The possible root cause for the problem reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism.
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