The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during out of box, they've noticed that devices on which the output of the cardiotome was devoid of the normally inserted protection cap which was free inside the plastic packaging.Additionally, the kind of cap is not the one used for the oxygenators but the one that is inserted on the tubes for the correct sterilization of the circuit.No patient involvement.
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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 november 1, 2019.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information).H4 (device manufacture date).H6 (identification of evaluation codes 11, 3331, 4114, 3259, 4307).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3259 - improper physical structure.Conclusions code: 4307 - cause traced to component failure.The sample was not returned; therefore, a complete investigation could not be performed.However, the photo that was provided was reviewed and confirmed the blue cap had fallen off of the reservoir outlet port.A representative retention sample from the same lot number was inspected and found to still have the blue cap attached.All oxygenators are 100% visually inspected at several points in the production process.It is likely that the cap fell off due to a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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