Health Canada — Medical Devices · Canada · 2020-04-08 · Type I
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Reported risk: Manufacturer received questions from clinicians exploring modifying their use of Prismax Control Units, in order to minimize exposure to COVID-19-positive patients. For example, clinicians may be using multiple extension lines to extend the length of the tubing set to allow placement of a Prismax Control Init outside of the patient's room. As per manufacturer, several significant risks could arise with this practice. To mitigate these risks, manufacturer is recommending following the setup instructions in the graphical user interface, as well as the warnings from the prismax operators manual. Failure to do so could result in serious patient harm.
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