Health Canada — Medical Devices · Canada · 2016-11-15 · Type II
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Reported risk: Beckman Coulter has identified an incompatibility between No Foam DxC Reagent (REF B64130) and the DxC Hydropneumatic Parts associated with No Foam Delivery. DxC No Foam Reagent is intended to prevent formation of foam and/or bubbles in the DxC waste system of the Hydropneumatic Subsystems. Over time, this incompatibility may lead to: breaks in no foam cap assembly (PN A84827), cracks in no foam waste collector (PN A60007/A64665), seepage outside no foam tubing (PN A10027, A10028, and A67123). This incompatibility does not affect No Foam's ability to perform its function and there is no impact to patient results. Cracks in the waste collector may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure. Cracks in the No Foam Cap and seepage from the No Foam Tubing may lead to exposure to No Foam.
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