A facility reported that after a mri, medical staff was not able to adjust the hakim valve due to dislocated strator.The patient did not experienced any symptoms or consequences due to the valve dysfunction, the patient had over drainage.The valve was implanted in 2009 and explanted on (b)(6), 2021.
|
Complaint sample was received for evaluation: dhr: lot number cjmbnp, conformed to the specifications when released to stock.Failure analysis: the valve was visually inspected; the stator was dislodged.The valve was dismantled and was examined under microscope at appropriate magnification: a bump mark was noted in the valve casing, and the steps on the cam mechanism are also damaged, also corrosion was noted on the stator.The cam magnets were controlled: the magnets passed.The root cause for the dislodged stator reported by the customer is due to the valve receiving a hard knock.The root cause for the damaged cam mechanism steps is due to the valve receiving a hard knock the root cause for the bump mark in the valve casing is due to the valve receiving a hard knock.The root cause of the corrosion, could not be clearly determined galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.
|