The device was not received for evaluation.Without the benefit of analyzing the device quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
|
This follow-up mdr is created to document the evaluation of the returned device.A titan otr pump and two cylinders were received for evaluation.Microscopic examination revealed rough and irregular surfaces noted on the detachment site of the short pump exhaust strain relief and the detachment site of the cylinder 2 exhaust tube indicating sufficient stress was exerted to separate the site.Microscopic examination revealed a group of partial separations within abrasion on the longer pump exhaust tubing, and the pump inlet tubing.These groups were not sites of leakage.Microscopic examination revealed a group of partial separations on the strain relief of the short pump exhaust tubing, indicating contact with unshod instrumentation.This was not a site of leakage.Surface abrasion was noted on the longer pump exhaust tubing and pump inlet tubing, indicating repetitive contact between surfaces.No functional abnormalities were noted with the pump or either cylinder.Based on examination of the returned product, it was concluded that the longer pump exhaust tubing and the pump inlet tubing had overlapped and abraded against one another.This positioning, in combination with device usage over time, could contribute to sufficient stress(s) to cause a separation in the shorter pump exhaust tubing.A separation of this type would then allow the loss of fluid, making the device inoperable.
|