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 was received for evaluation.Examination of the returned component revealed a separation at the strain relief of the longer exhaust tube of the pump.Testing revealed this to be a site of leakage.Quality concluded that the tubing had overlapped and abraded against one another while in-vivo.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to separate the longer exhaust tube of the pump at this site.A separation of this type would then allow the loss of fluid, making the device inoperable.
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