(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was not any longer available for investigation.The oxygenator was scrapped by the customer.A review of similar complaints was performed and the incident was investigated within a previous complaint ((b)(4)) with the following outcome: based on the reported event and our investigation, the event was caused by use that is beyond the use described in our labeling and approved intended use.The instructions for use g-152 (art.# 70105.1053 v04, common device name: ifu-usca: quadrox-id adult g-152) clearly state the following: chapter 4: warnings and precautions, page 7: when using the oxygenator, methylene blue must not be administered directly before or during perfusion.Use of methylene blue may affect the permeability of the membrane and result in consequences for the patient.Based on this and the information available at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.The oxygenator in question operated within maquet cardiopulmonary specifications.The reported incident was most probable caused by off label use.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.
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