The device, used in treatment, was returned for evaluation.A visual inspection found no defects.The functional evaluation found the device performed as expected.We have not been able to establish a relationship between the device and the reported events.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances in the past three years.Alarm thresholds are set after thorough testing and are always set to ensure the complete safety of the patient.It is possible in extreme cases that the alarm may trigger inadvertently.The ifu can provide further guidance.Ensure canister and tubing and renasys softport are installed correctly and without kinks to avoid leaks or blockages in vacuum circuit.No further actions are deemed necessary at this stage.However, 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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