Distribution history: this complaint unit was manufactured at csi on 1/17/2023 under wo #(b)(4).Manufacturing record review: dhr 322809 was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: not applicable.Service history record: not applicable.Historical complaint review: a review of the 2-year complaint history showed one similar reported complaint condition.Product receipt: the complaint unit was not returned.Visual evaluation: visual examination of the complaint unit was not possible as the unit cannot be returned.Functional evaluation: a functional evaluation of the unit was not possible as the unit cannot be not returned.Root cause: the root cause is attributed to end user error.The ifu states the pressure to use on the device is not to exceed 24 psi.The customer stated the pressure was set to 60 psi, more than double the specified pressure indicated by the ifu.The verbiage suggests the customer concedes the line may have exceeded 60 psi for a short period of time.Note: complaint confirmation is based on the image provided and the information concerning the exposure to high pressure.A review of the ifu confirms clear instruction to not exceed 24 psi when pressurizing the line to the filter.Due to the damage when this unit was exposed to excessive pressure, hhe-23-0193 for coda in-line filters was submitted.Coopersurgical will continue to monitor this complaint condition for trends.
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