This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 23, 2022.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 4210, 23).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 4210 - leakage/seal.Investigation conclusions: 23 - manufacturing deficiency.The returned sample was pressurized with water found to leak at approximately 300 mmhg.Upon further inspection, it was noted that the thermistor tab was not in the upright position.The thermistor was able to be removed with little force; however, it was noted that bonding agent was present within the port.The likely cause is the thermistor had an insufficient amount of bonding agent applied.This would allow the thermistor to be inserted into the port and remain in the port, but not be securely affixed in the port to where it would leak when pressure was applied.A representative retention sample was reviewed with no visual anomalies observed with the arterial thermistor.The thermistor was also attempted to be removed; it was securely affixed to the port.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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