The renasys pump device, used in treatment, has not been returned for evaluation.All provided information has been reviewed, we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable cause includes a component failure.No batch/lot number has been provided, therefore a review of the device history records has not been possible, however, at this time, we have no reason to suspect that the product did not meet specifications 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.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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