Terumo will not receive the device for evaluation; however, 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.For this reason, terumo references evaluation conclusion code 11.
|
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass there was a temperature probes issue.As per the subsidiary, the temperature being measured is consistently 5 degrees celsius different than the bladder temperature and their cardioquip temperature.Both the bladder temperature and cardio quip temperature appear to be consistent with each other.The temperature being measured from capiox oxygenators was dramatically different and consistently 5 degrees off.Liva nova inspected the s5 heart lung and temperature modules and they are reportedly reporting accurately.Additionally, the capiox temperature probes that are attached to the cp50 cardioplegia set were accurate.As a mitigation, the user facility used heater cooler temperature and bladder temperature to determine blood flow temperature to resolve the problem.No known consequence or health impact to patient.Product was not changed out.Procedure was completed successfully.
|
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 april 12, 2024.Upon further investigation of the reported event, the following information is new and/or changed: g3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 3331, 4114, 3221, 4315).The sample was not returned for evaluation, nor were any pictures provided; therefore, a thorough investigation could not be performed.Without a returned device or pictures being provided, a thorough investigation could not be performed, and a definitive root cause could not be identified.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|