Model Number 3CX*FX15RW40C |
Device Problem
Leak/Splash (1354)
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Patient Problems
Autoimmune Disorder (1732); Death (1802); Lupus (1956)
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Event Date 12/05/2019 |
Event Type
Death
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Manufacturer Narrative
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Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
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Event Description
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The user facility reported to terumo cardiovascular, that during cardiopulmonary bypass (cpb) a plasma leak was observed.Per user facility, the patient was in for davinci robotic removal of left atrial myxoma and the closure of a patent foramen ovale (pfo) with complications that resulted in over 9 hours on cardiopulmonary bypass support.Per user facility there was no performance degradation in the first unit.The unit was changed out after 6.5 hours, however because of patient's instability, cpb was reinitiated and they were on bypass for another 3 hours.The second unit developed a plasma leak again with no downturn in gas exchange performance.The patient was weaned from bypass on the second oxygenator with an attempt of extracorporeal membrane oxygenation (ecmo).The patient received lots of blood and crystalloid however did not survive the procedure.In addition according to user facility given the patient¿s history, copious amounts of transfusion, no performance degradation and the length of time on cpb.They were not surprised that some plasma leakage would occur.It is unknown it there was delay.It is unknown if there was blood loss.
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Manufacturer Narrative
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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 january 10, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 11, 4114, 3221, 4315).The affected sample was not returned, so a thorough investigation could not be performed and a definitive root cause could not be determined.A review of device history record and incoming inspection record of the involved material code or lot number confirmed that there were not any indications of anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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Search Alerts/Recalls
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