The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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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.This positioning, in combination with device usage over time, could contribute to sufficient stress to separate the longer exhaust tubing of the pump.A separation of this type could then allow the loss of fluid, making the device inoperable.Because these components were released according to manufacturing and quality control procedures, it was concluded that the observed instrument separation on the inlet tube of the reservoir occurred after the device packaging was opened.In addition, because the expected use of this device combined with the observed separation would have resulted in an earlier detected fluid loss, it was concluded that the separation most likely occurred during or after explant.This separation is not associated with the cause for failure.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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