It was reported that, after 48 hours of npwt treatment, a renasys touch non connect 4th ed device began to show ¿pipe or recip.May be blocked¿ alarm and stopped pumping.It is unknown how was the treatment was completed.No injury was reported as a consequence of this problem.
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The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.While a blockage in the npwt system (pump/canister/dressing) may lead to a loss of negative pressure, it will not directly cause or contribute to serious injury or death, even in a clinical setting.Additional conditions must also exist (e.G.Surgical / treatment conditions; patient factors; the unavailability of back-up or alternate therapies for greater than 24 hours) before an injury could possibly occur, and even under those conditions, the risk of patient harm is low.This event is considered not reportable pursuant to 21 cfr part 803.
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