It was reported that, during npwt, a renasys go displayed an alarm.Two weeks ago, patient had experienced it but was not aware so the machine stopped working for two days and ended in an infection.It is unknown how treatment was completed.Further information is not available.
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H3, h6: the device was not returned for complaint evaluation, all supplied information has been reviewed and we cannot confirm the reported event.As noted in the case report the patient was unaware that the device had stopped working.Without negative pressure being applied exudate can collect on the wound bed leading to infection.Medical review concluded; no relevant clinical medical information can be provided to conduct a thorough medical assessment.The patient's current condition is unknown.Should any additional clinical information be provided this complaint will be re-evaluated.A documentation review conducted confirming the instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Complaint history has recorded previous occurrences of this nature.Smith and nephew can confirm the device met manufacturing specifications upon release for distribution and continue to monitor for adverse trends relating to this product range.This investigation is now complete, confirming the event is not related to a manufacturing problem and that no corrective actions are deemed necessary.
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