Health Canada — Medical Devices · Canada · 2018-10-26 · Type II
As described by Health Canada — Medical Devices: Quadrox-i Neonatal Oxygenator, Quadrox-i Neonatal Oxygenator with Integrated Hardshell Reservoir, and Custom Pack With Softline (2018-10-16)
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Reported risk: All variants and sets of QUADROX-i Neonatal oxygenators are supplied with a separate reducing screw adapter 1/4" x 3/16". It can be screwed onto the blood inlet and blood outlet connectors of the QUADROX -i Neonatal oxygenator to reduce the port to size 3/16". Maquet has received complaints in relation to leakage at the QUADROX -i Neonatal blood inlet connector. 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 connector-adapter 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. Using the QUADROX -i Neonatal oxygenator in conjunction with the reducing screw adapter 1/4" x 3/16" can result in clinically relevant loss of prime before patient connection or blood loss during patient connection. Clinicians need to judge whether or not to replace the device, but device replacement is the mitigation of choice if leakage exceeds the clinically acceptable limit. Risks associated with device replacement during patient connection include but are not limited to interruption of cardiopulmonary bypass, blood loss and infection. Maquet cardiopulmonary thus recommends not using the adapter at the blood inlet connector of the QUADROX -i Neonatal oxygenator. Using the device without the reducing screw adapter at all or using an alternative method of tubing reduction safely allows operators to set up and operate cardiopulmonary bypass without the potential necessity of device replacement in case of leakage. Maquet's recommendation outweighs the risks associated with device use with the reducing screw adapter. Maquet has not received any complaints associated to serious injuries or deaths due to a leakage at the blood inlet connector.
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