The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, it was noted that the maquet hemoconcentrator luer does not lock firmly.No known impact or consequence to patient.Product was not changed out.Procedure was completed successfully.
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The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.Evaluation of the returned sample confirmed that the luer was not able to lock around the threads on the reservoir port.When the design of the 3cx reservoir lid was compared against the design of the (b)(6) product, or 1cx reservoir, it was found that the wall thickness of the ports differed.The wall thickness of the wall opposite of the threads on the ports is thicker on the (b)(6) reservoir ports.This thicker wall helps keep the threads of the port and luer engaged.The luered ports on the reservoir lid are checked in process for iso 594-1, the internal sealing taper, using a calibrated luer gauge.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
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