The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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A titan otr pump, two cylinders, and a reservoir were received for analysis.Partial separations within abrasion were noted on the longer exhaust and inlet tubing of the pump.These were not sites of leakage.A separation, adjacent to a confined area of abrasion, was noted in the exhaust tube of both cylinders 1 and 2 near the tube/strain relief junction.These were both sites of leakage.Partial separations with in abrasion were noted on both cylinder exhaust tubes.These were not sites of leakage.No functional abnormalities were noted with the reservoir.Based on examination of the returned product, it was concluded that the abrasion marks noted on the both exhaust tubing and inlet tubing of the pump matched in such a way to conclude that they had overlapped and abraded against one another while in-vivo.This then may have caused the exhaust tube of cylinders 1 and 2 to be kinked onto themselves for a period of time.This positioning, in combination with device usage over time, may contribute to sufficient stress(s) to separate the cylinder exhaust tubing at these sites.Separations of this type could then allow the loss of fluid, making the device inoperable.Review of lot # for complaint trend, nonconforming report and capa review.No trends noted.
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