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 additional lot number received and the evaluation of the returned device.An otr pump and two cylinders were received for evaluation.Examination and testing of the returned components revealed a separation at the tubing/strain relief junction of cylinder 1.Testing revealed this to be a site of leakage.The separation appears to be within an area of confined abrasion.No visual or functional abnormalities are noted with the pump or cylinder 2.Based on quality's examination, quality concluded the exhaust tube of cylinder 1 was most likely kinked onto itself, abrading enough to cause a separation in the tubing.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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