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As reported on an excel spreadsheet received from codman "an edsiii, 821730, attached to an evd drain, developed a crack developed at the access port and the drain was removed.It was noted that the drain was not longer draining and there was air in the drain line.The neurosurgical registrar reviewed the drain and attempted to flush the drain with saline.The registrar noted that saline was squirting out through the cranial port,( the access port of the drain closest to the patient).A crack was noted at the access port.A routine ct scan was performed as the drain was not functioning, and it was noted that new intraventricular gas was seen.The drain was removed on the (b)(6) 2018.No adverse event was reported.Additional information has been requested.
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Additional information: resulting in patient harm: air embolism.Additional medical/ surgical intervention needed.Patient is not part of a clinical study.Patient information: n/a.Natus completed their investigation on (b)(6) 2018.The investigation results are as follows: investigation summary: the customer reported: as reported by the ous affiliate, an edsiii, 821730, attached to an evd drain, developed a crack developed at the access port and the drain was removed.It was noted that the drain was not longer draining and there was air in the drain line.The neurosurgical registrar reviewed the drain and attempted to flush the drain with saline.The registrar noted that saline was squirting out through the cranial port,( the access port of the drain closest to the patient).A crack was noted at the access port.A routine ct scan was performed as the drain was not functioning, and it was noted that new intraventricular gas was seen.The drain was removed on the (b)(6) 2018.The investigation of the eds did confirm the problem reported by the customer.The lot number is unknown, product code 82-1730.Investigation methods/evaluation results: the eds iii was visually inspected, a crack in the plastic of the patient line stop cock was found.The current quality inspection for these assemblies is established to 100% test for leaks and blockage.A search for relative complaint for the same issue with the same product code and lot number for the last year was not possible as the lot number is unknown review of the history device records was not possible as the lot number is unknown.A review of complaint records for the previous 12 months could not be performed as no lot number information was provided.The most recent complaint and smt presentation was reviewed and did not show that this product family exceeded its upper control limit for complaints.Root cause category-codman : man : user error/misuse/off label use failure code-codman : nic : external drains : broken/ separated : 3way stopcock root cause description-the root cause of the problem reported by the customer is probably due to over tightening of the stop cock.As noted in the ifu connectors should be finger tightened only.Is further corrective & preventative actions proposed? no document rationale for no corrective action.No corrective action is needed based on the results of the evaluation.This complaint is now deemed closed.
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