Titan otr pump, cylinders 1 and 2, and connector / tubing were received for evaluation.Abrasion was noted on both exhaust tubes and the inlet tube of the pump.A group of partial separations, surrounded by abrasion, were noted on both exhaust tubes of the pump.These were not sites of leakage.The surfaces of the detachment site of the inlet tube of the pump appear to be rough and irregular, indicating stress was exerted.No functional abnormalities were noted with either cylinder 1 or cylinder 2.Abrasion was noted on the detached connector/tubing.No functional abnormalities were noted with the detached connector/tubing.Based on examination of the returned product, it was concluded that while in-vivo both the exhaust tubes and inlet tube of the pump had overlapped and abraded against one another.While no functional abnormalities were noted during testing with the returned components, microscopic examination of the surfaces of the inlet tube detachment end between the pump and reservoir revealed rough and irregular surfaces, indicating stress was exerted.Based on the overlapping of the pump tubes, in combination with device usage over time, this could contribute to sufficient stress to separate the exhaust tubing of the pump.A separation of this type would then allow the loss of fluid, making the device inoperable.A review of the device history record confirmed the devices from this lot met all specifications prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
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