FDA issues CardioQuip, Wickimed warning letters for adulterated devices

Updated 16 March 2022 to clarify CardioQuip's product.*

The US Food and Drug Administration (FDA) recently issued warning letters to device manufacturers CardioQuip, LLC, for its Modular Cooler-Heater Model MCH-1000 devices and to Wickimed Medical Equipment Manufacturing Co., Ltd., for its Sterile Single Use Disposable Electrodes.

The FDA’s letter to CardioQuip requests that the company cease commercial distribution of certain Modular Cooler-Heater (MCH) add-on modules,* which have been changed in a way that the agency said makes them misbranded and adulterated. This does not affect the distribution of its Modular Cooler-Heater MCH-1000 devices. CardioQuip said it is working directly with the FDA to resolve the issues in the warning letter.

CardioQuip currently holds a 510(k) clearance for the CardioQuip Modular Cooler-Heater Model MCH-1000 devices, issued in November 2010. Since that device was cleared, the company has made significant changes to the cardiac heater-cooler product, including addition of an optional airflow hood, a dripless external hose kit, and thermoelectric cooling technology in some models, without a new 510(k) premarket notification submission.

“The final significant change outlined in this warning letter, the addition of thermoelectric cooling technology, is a major operating principle change as the original 510(k) (K102147) was cleared with the use of optional compressor cooling and not thermoelectric cooling. These and other changes could significantly affect the safety or effectiveness of the device,” FDA wrote in the letter, issued on 11 February 2022.

Since the company did not submit a new premarket notification submission, the FDA has deemed that the modified MCH devices are misbranded. The warning letter also stated that the MCH devices are adulterated because CardioQuip does not have an approved application for premarket approval or an approved application for an investigational device exemption.

Additionally, FDA said the MCH devices are adulterated based on a lack of conformity with the current good manufacturing practice requirements, which were observed during an August 2021 inspection of the College Station, Texas, facility. For example, when the company added the optional airflow hood to the MCH devices, the company did not validate the change to ensure that it met the intended use of the device. The company’s validation of the change only addressed the impact to temperature of the unit, but not the potential for microbiological infection of patients. Similarly, the firm modified the external tubing of the MCH devices, changing to a PVC antimicrobial tubing, but did not use an approved protocol for the microbial testing.

The FDA also cited CardioQuip’s failure to implement corrective and preventive action related to an increase in complaints of device contamination with nontuberculosis mycobacteria (NTM) in December 2020. The FDA had earlier warned health care providers at the potential risk of NTM infection during cardiac surgery with CardioQuip’s MCH device and has issued safety communications about the risk of NTM with heater-cooler devices since 2015 (RELATED: FDA warns of infection risk with CardioQuip heater-cooler, Regulatory Focus 30 September 2020).

In the warning letter, the FDA noted that the company did not perform an “accurate” investigation of the infection complaints. “Your [corrective and preventive action] records state your firm has not linked your device to patient infection; however, your firm has reported events in which you confirmed your device was linked to infection,” the letter stated.

FDA also took the company to task for failing to maintain an adequate complaint process. For example, CardioQuip received 11 complaints in July 2021 related to hospitals finding bacterial contamination on several of the MCH devices. The company’s records suggest these isolates did not match the environmental and patient isolates and as a result no additional investigation was conducted. But CardioQuip failed to investigate the level of contamination or the cause, FDA said.

Wickimed warning
The FDA also issued a warning letter to China-based Wickimed for its Class II Sterile Single Use Disposable Electrodes, stating that the devices are adulterated. The FDA is taking steps to refuse entry of the devices into the US, known as detention without physical examination, until the violations are addressed.

An inspection of the firm in HuiZhou, China, in September 2021 revealed that facility was not meeting current good manufacturing practice requirements, had failed to establish and maintain procedures for evaluating complaints, could not validate its sterilization procedures, did not maintain adequate procedures to control the design of the device, did not maintain document control procedures, and did not maintain device history records.

CardioQuip warning letter, Wickimed warning letter

FDA issues CardioQuip, Wickimed warning letters for adulterated devices

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