There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).Based on provided picture analysis, no sharp edges are visible inside the pump.Only dark traces on the internal surfaces could be identified which were identified by the technician in charge as corrosion due to cleaning products.Through follow-up communication livanova learned that the hospital uses several types of chemicals to clean the pump.Investigation is still ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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