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 4, 2020.Upon further investigation of the reported event, the following information is new and / or changed: b5: (describe event or problem - added new information).D4: (additional device information - added expiration date).D5: (operator of device).E1: (added reporter name and address).E2: (health professional - added new information).E3: (occupation - added new information).G4: (date received by manufacturer).G7: (indication that this is a follow-up report).H2: (follow-up due to additional information).H4: (device manufacture date).H6: (identification of evaluation codes 2692, 11, 3331, 4114, 3221, 4315).Patient code: 2692 - no known impact or consequence to patient.Method code #1: 11 - testing of device from same lot / batch retained by manufacturer.Method code #2: 3331 - analysis of production records method code#: 3 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 4315 - cause not established.The affected sample was not returned so a thorough investigation could not be performed.A representative retention sample was reviewed with no visual damage, including the area of the venous thermistor.The thermistors were also checked for functionality and found to be functional.All capiox units are 100% visually inspected at several points in the production process.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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