Device was not evaluated due to it was not returned for investigation.We have now completed our investigation into the reported complaint.As of today, no product return or further information for this complaint has become available preventing a more thorough investigation.If the product becomes available in the future, this case will be reopened.An investigation into the manufacturing paperwork associated with this product has been unable to be carried out due to no lot number being provided.Each pump is functionally tested by the supplier before shipment to smith & nephew.Any pump which fails to meet the predetermined acceptance criteria is rejected.As this pump has been released for sale, it can be confirmed that the device has passed all functional testing.On this occasion we are unfortunately unable to reach a definitive root cause of the problem due to insufficient information available for the device in question, however smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.
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