The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, presence of crack on the sampling line with leakage during the priming with water. no patient involvement.Product was 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 january 30, 2019. upon further investigation of the reported event, the following information is new and/or changed: 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).H6 (identification of evaluation codes 10, 11, 3331, 3259, 4307).The returned sample was visually inspected and a crack along the female l-shaped connector was found.The exact lot number of the oxygenator was not known; therefore, a representative retention sample from each of the potentially affected lot numbers were visually inspected, and was confirmed to have no damages or cracks on the l-shaped connector.Investigations of similar events, replication testing found that this crack appears on the part when the l connector is over tightened on a port.It is likely that during setup of the circuit, the l connector had been over-tightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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