The user facility reported to terumo cardiovascular that during pre-cardiopulmonary bypass, the venous reservoir was defective.Specifically, a crack was noticed on the top of the venous reservoir.There was a delay for 10 minutes; product was 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 december 21, 2018.(b)(4).The sample was not returned for investigation and the lot number was not provided; therefore, a complete investigation could not be performed.Additional information received states that the damage was caused by an associate in the facility storeroom.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
|