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, a reservoir, and a piece of detached exhaust tubing were received for evaluation.Examination and testing of the returned components revealed a separation the exhaust tube/connector junction of the detached exhaust tube.Testing revealed this to be a site of leakage.The separation appears to be rough and irregular, indicating sufficient stress was exerted.Surface abrasion is noted on all tubes and all strain relief of the pump and on the exhaust tube of cylinder #2.Partial separations within abrasion are noted on all tubes of the pump.Testing revealed these not to be sites of leakage.An aneurysm is noted on the bladder of cylinder #1 and cylinder #2.Testing revealed these not to be sites of leakage.A partial separation is noted on the detached exhaust tube.Testing revealed this not to be a site of leakage.No functional abnormalities are noted with the pump, cylinder #1, cylinder #2, or the reservoir.Based on previous quality simulations and examination of the returned product, quality concluded that the rough and irregular surfaces associated with this separation indicates that sufficient stress(s) was exerted on the detached exhaust tube at the connector junction to separate the site while in-vivo.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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