Quest received the suspect device from (b)(6).After decontamination of the sample, testing of the device noted an occlusion in the filter.After clearing the occlusion, there were no other occlusions detected, indicating the occlusions were not a result of excessive solvent.The customer reported that the sets were changed out every 96 hours.Per the device ifu, it is recommended to change out the set every 72 hours.Additionally, it is noted that if the sets are utilized for lipid infusions, leaving solutions for this length of time can cause the lipid solution to warm and stop line patency, leading to occlusions.The root cause of this complaint was noted to be leaking due to occlusion of the set due to failure to swap the set out after 72 hours.Quest has concluded its investigation of this complaint condition.Quest will continue to monitor complaint trends.
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