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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A titan otr pump, two cylinders, and piece of detached inlet tubing were received for evaluation.Examination and testing of the returned components revealed a separation near the strain relief on the longer 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.Partial separations are noted on the inlet tube of the pump.Testing revealed these not to be sites of leakage.Surface abrasion is noted on all tubes and all strain relief of the pump.A group of striations are noted on the exhaust tube of cylinder #1, indicating contact with unshod instrumentation.Testing revealed these not to be sites of leakage.A partial separation is noted on the exhaust tube of cylinder #1.Testing revealed this not to be a site of leakage.No functional abnormalities are noted with cylinder #1, cylinder #2, or the detached inlet tubing.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 longer exhaust tube of the pump to separate the site while in-vivo.A separation of this type would then allow the loss of fluid, making the device inoperable.Quality reviewed the manufacturing records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.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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