The hospital reported vasoview hemopro 2 co2 line connected to the btt port intermittently showed 'occluded' on the co2 control unit.They adjusted the gas line connection (to be a little looser), and it worked for a while, then showed occluded again.Another hemopro kit was opened to complete the procedure.The same issue happened with the replacement kit.No delay on the procedure aside from a couple minutes to open a new kit.No patient injury.Related to tw (b)(4).
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Trackwise#: (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation on 03/15/2024.An investigation was conducted on 03/19/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.The harvesting device, cannula and btt were returned for evaluation.There were no visual defects observed on the intact cannula or the c-ring.There were no visual defects observed on the intact harvesting device.There were no visual defects observed on the intact btt.A mechanical evaluation was conducted.The btt was able to be inflated.No visual defects were observed on the silicone btt.A 5cc syringe, filled with saline was attached to the co2 line on the btt and squeezed the syringe to spray the saline.There was no backflow observed in the co2 line.Based on the returned condition of the device as well as the evaluation results, the reported failure "improper flow or infusion" was not confirmed.Specific actions for the reported failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.The lot # 3000350116 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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