The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the centrifugal pump adapter is not holding the head in properly.As per the user facility, it was held firmly by hand for the entire case by a second assistant, and used unit until replacement is received.No known impact or consequence to patient.Product was not changed out.Procedure was completed successfully.
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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 july 28, 2020.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 4114, 3221, 4315) method code: 4114 - device not returned results code: 3221 - no findings available conclusions code: 4315 - cause not established the sample was not returned; therefore, a thorough investigation could not be performed and a definitive root cause could not be determined.Retention samples are not kept for this product line.Adapters are 100% tested prior to release including pump interface testing.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
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