It was reported that, during npwt, the renasys go pump was alarming "blockage full".The renasys go canister 300ml had little to no drainage and crystals had released from solidifier pack into canister.The pump, the dressing, and the cannister were replaced, and the next day the alarm show off on the new renasys go pump.Patients wound sat in secretion and progress towards healing took a setback.Patient went to wound clinic and the npwt was discontinued.No other complications were reported.
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H6: the device used in treatment was not returned for evaluation, with all information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable root cause may include kinks, leaks in the vacuum circuit or a component failure.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.Instructions for use contains recommendations and precautionary statements for proper use of the product.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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