FDA WARNING_LETTER - Spectrum Medical Ltd. - April 27, 2023

On September 29, 2023, the FDA issued a Warning Letter to Harrier 4, Meteor Business Park, Gloucester, UK, following an inspection from April 24-27, 2023. The firm manufactures Quantum Perfusion Systems, including oxygenators, tubing sets, roller pumps, and heater coolers, which are medical devices.

The FDA determined the firm markets several devices with indications beyond their cleared premarket notifications (510(k)s), constituting unapproved-device violations. Specifically, Quantum Pureflow Centrifugal Pumps, Quantum Roller Pumps, Quantum Power Supply Lite, Quantum SuperPAC cannulas, Quantum Ventilation Module, Quantum SuperPAC Tubing Set, and Charlotte Frame Configuration are marketed for extended durations (e.g., 29 days vs. 6 hours) and uses (e.g., ICU, patient transport) not cleared for cardiopulmonary bypass (CPB) procedures. These changes are considered major modifications affecting safety and effectiveness, requiring new 510(k) submissions per 21 CFR 807.81(a)(3)(ii). The devices are deemed adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act.

Additionally, the inspection revealed Quality System Regulation (QSR) violations, rendering devices adulterated under section 501(h). Violations include failure to