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.
|
Titan otr pump and cylinders 1 and 2 were received for evaluation.Abrasion was noted on the inlet tube of the pump.No functional abnormalities were noted with the pump.Abrasion was noted on the exhaust tubing of cylinder 1 and cylinder 2.Partial separations, surrounded by abrasion, were noted on the exhaust tubing of cylinder 1 and cylinder 2.These were not sites of leakage.No functional abnormalities were noted with cylinder 1 or cylinder 2.The information received indicated the device was not able to cycle, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
|