SPECTRUM MEDICAL SRL — Class II: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High
Spectrum Medical SRL has initiated a Class II recall for the Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W due to reports of blood-to-glycol leaks within the device. The recall is currently listed as ongoing and affects model HX55V-S0W.
This recall affects Spectrum Medical SRL, healthcare facilities performing cardiopulmonary bypass procedures, and clinical teams utilizing Quantum PureFlow heat exchangers with glycol-based heater/cooler systems.
A blood-to-glycol leak during extracorporeal circulation presents a significant risk of systemic contamination and patient injury during high-flow procedures. The source indicates the device is designed for use with glycol-based heat transfer fluids, suggesting a potential failure in the physical barrier or material compatibility under operational conditions, which may necessitate a review of design verification data for similar Class II heat exchangers.
Immediate identification and quarantine of affected Model HX55V-S0W units is required. Regulatory teams should update risk management files to reflect heat exchanger leak potential and review heater/cooler fluid compatibility assessments for similar extracorporeal devices.
Class II. Reason: Due to blood-to-glycol leak in the heat exchanger.. Product: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Standard Heat Exchanger is intended to be used with a compatible Heater/Cooler system to heat/cool blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration with a maximum flow rate of 8 l/min. Quantum PureFlow Standard Heat Exchanger is a single use device which allows heating/cooling the blood during extracorporeal circulation. The device is sold sterile in a blister pack in a multiple box of 4 units. Device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating. The device has been designed to be powered by heaters coolers that use water or a glycol-based heat transfer fluid (HTF). Component: N/A. Firm: SPECTRUM MEDICAL SRL (Mirandola Italy). Status: Ongoing.
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