Health Canada — Medical Devices · Canada · 2013-01-07 · Type II
As described by Health Canada — Medical Devices: Terumo Advanced Perfusion System 1 (Roller Pump Occlusion Malfunctions)
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Reported risk: Terumo Cardiovascular Systems has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. Occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion.
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