FDA WARNING_LETTER - CardioQuip, LLC - September 17, 2021

The FDA issued a Warning Letter to CardioQuip following an inspection from August 19 to September 17, 2021, for violations related to their cardiac heater-cooler product, the MCH-1000 Device.

The firm made significant design changes to the MCH-1000 Device, including an optional airflow hood, a dripless external hose kit, and thermoelectric cooling technology, without submitting a new 510(k) premarket notification. These modifications, which could affect device safety and effectiveness, render the Modified MCH Devices misbranded under 21 U.S.C. § 352(o) and adulterated under 21 U.S.C. § 351(f)(1)(B) due to the lack of an approved PMA or IDE.

Additionally, the devices are adulterated under 21 U.S.C. § 351(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820). Deficiencies include: 1. **Failure to control design (21 CFR 820.30(a))**: Inadequate design validation for changes (e.g., microbial load specification, airflow hood, external tubing, thermoelectric cooling) and insufficient risk analysis (e.g., delayed consideration of aerosolized bacteria hazard). Design inputs were also ambiguous. 2