CardioQuip Modular Cooler Heater

Description of Event or Problem

A CardioQuip (CQ) technician notified CQ Service that the internal tubing of this device was suspected of contamination during an on-site inspection and submitted pictures to CQ for review. The CQ Director of Operations and Epidemiology reviewed the pictures and recommended that the customer perform a Quarterly Cleaning and Disinfection procedure according to the device Instructions For Use (IFU). HPC testing is also recommended to provide a quantitative assessment of water quality. No patient involvement was reported. HPC test results outside of CQ specifications for water quality were received on 07/10/2026, indicating device contamination.

Additional Manufacturer Narrative

A CardioQuip technician submitted photos of tubing to Epidemiology for investigation during a device inspection. Due to the discoloration of the tubing, Epidemiology recommended that the device receive HPC testing to provide a quantitative assessment of water quality. Following test results outside of CardioQuip specifications, CardioQuip recommended that either (1) the customer reperform cleaning and disinfection procedures detailed in the IFU and reperform HPC testing, (2) the device receive an internal water pathway replacement, or (3) the customer participate in CardioQuip's trade-in program. The customer chose to perform an internal water pathway replacement to repair the device. The device has undergone repair, returning it to specification.