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 otr pump, two cylinders, and a reservoir were received for evaluation.Examination and testing of the returned components revealed a separation within abrasion at the exhaust tube/strain relief junction of the serialized exhaust tube of the pump.Testing revealed this to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.No functional abnormalities are noted with cylinder #1 or cylinder #2.Quality concluded that while in-vivo both the exhaust tubes and inlet tube positioned themselves in such a way that caused them to overlap and abrade against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the serialized exhaust tube of the pump at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.
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