The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up the temperature probe was loosen.It is unknown whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
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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 june 23, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).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; therefore, a thorough investigation could not be performed.A representative retention sample was reviewed with no visual damage, including the area of the venous thermister.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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