It has been reported that a progav shunt system (#fx449t) was unable to adjust the pressure of the valve during implantation.This occurred during surgery on an 8-month-old infant.After implantation, the valve should be normally adjustable, but it was unable to change the high flow rate.This is extremely rare - the valve was replaced with another of the same type.The hospital department had to get a new valve from the or's stock and replace it.This affected the operation time, which was extended by 5 minutes.For the patient, this meant an extension of the operation time, which led to an increased risk.
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Investigation: visual inspection: during the investigation, a deformation/damage of the outer housing of the progav 2.0 could be determined.Permeability test: a permeability test has shown that all components are permeable.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, deposits were found.Result: based on our investigation results, we can determine adjustment difficulties in the progav 2.0 valve.The determined damage and the deposits can be named as the cause for the functional impairment.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.How the damage to the outer housing occurred is not clear to us at the time of the investigation.However, based on our documentation, it can be ruled out that the valve was shipped with this defect.
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