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 (b)(6) 2019.Upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added expiration date).(date received by manufacturer).(indication that this is a follow-up report).(follow-up due to additional information and device evaluation).(device evaluated by manufacturer).(device manufacture date).(identification of evaluation codes 10,11, 3331, 3259, 25).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 25 - cause traced to manufacturing.The affected sample was reviewed upon receipt confirming the missing arterial thermistor.The most likely cause is the thermistor had no or an insufficient amount of bonding agent applied.This would allow the thermistor to be inserted into the port and remain in the port for a period of time, but not be securely affixed in the port to where it would fall out after packaging.A training was conducted with the production associates to make them aware of this event and to ensure that all thermistors, and other components, are properly assembled and inspected on the reservoir and oxygenator.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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