Health Canada — Medical Devices · Canada · 2019-05-24 · Type II
As described by Health Canada — Medical Devices: Custom Pack with Softline, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir (2019-05-12)
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Reported risk: Maquet Cardiopulmonary has received complaints in relation to leakage at the QUADROX-i Neonatal blood inlet connector. Internal investigations have revealed that the leakage only occurs if the enclosed reducing screw adapter 1/4"" x 3/16"" is screwed onto the blood inlet connector of the QUADROX-i Neonatal Oxygenator. The leakage occurs due to a non-conforming blood inlet connector that, in conjunction with the use of the screw reducing adapter 1/4"" x 3/16"", does not result in a tight connectoradapter connection. The combination of the reducing screw adapter 1/4"" x 3/16"" with the blood outlet connector or the use of the blood inlet connector directly to tubing does not exhibit any leakage.
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