The user facility reported to terumo cardiovascular a non-functional temperature measurement system.It is unknown when this event occurred, whether there was a delay, whether the product was changed out, whether there was blood loss, whether the surgery was completed successfully or if there was any patient effect.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 october 24, 2019.Upon further investigation of the reported event, the following information is new and/or changed: g4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 11, 4114, 3259, 4307).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 4114 - device not returned.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The affected sample was not returned for evaluation, so a thorough investigation could not be completed.A representative retention sample from a variety of product/lot number combinations were tested and found to be functioning properly.The root cause of the issue has been determined to be a high insertion force during assembly of the thermistor into the oxygenator module coupled with exposure to extreme temperature fluctuations.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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