The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during setup, the shunt line had an element which was unsoldered.It is unknown whether the product was changed out, whether there was a delay in the procedure or if there was any effect on the patient or results of the surgery.Due to the unknown information for this event, it is being reported.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 april 29, 2020.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) d10 (device availability - added date returned to manufacturer) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 10, 11, 3331, 3259, 25).Method code #1: 10 - testing of actual/suspected device method code #2: 11 - testing of device from same lot/batch retained by manufacturer method code #3: 3331 - analysis of production records results code: 3259 - improper physical structure conclusions code: 25 - cause traced to manufacturing.The affected sample was inspected upon receipt confirming insufficient bonding on the connector for the arterial pigtail.A representative retention sample was reviewed and found to have an appropriately bonded arterial pigtail.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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