It was reported that canister is blocking the negative pressure coming from the device to the wound bed, the exudate is not passing from the wound bed to the canister.After a canister of the same batch had the same issue, a different canister batch was tried and no issue.This issue was identified during procedure and the procedure was completed with a canister of a different batch.The canister from the hospital was tested by s+n team with a different renasys go device, to test if the issue was with the device and not the canister, but the same issue of canister being blocked was seen.No harm or injury reported.
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H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may be due to the reported blockage or a component failure.The ifu offers further guidance.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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