Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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This follow-up mdr is created to document the evaluation of the returned device.A titan genesis pump, two cylinders, and a piece of detached connector tubing were received for evaluation.Examination and testing of the returned components revealed an aneurysm in the bladder of cylinder #1.Testing revealed this to be a site of leakage.No functional abnormalities are noted with the pump, cylinder #2, or the detached connector tubing.Quality concluded that while in-vivo enough pressure may have been exerted to result in an aneurysm on the bladder of cylinder 2.Quality further concluded that this pressure, in combination with device usage, could contribute to sufficient stress (s) to separate the bladder at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information no further corrective action is required at this time.
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