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WARNING LETTER
CMS# 671243

March 21, 2024

Dear Mr. Augustine:

During an inspection of your firm located at 7656 W. 78th Street, Bloomington, MN 55439 on 09/06/2023 through 09/19/2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of various class II patient warming devices including the HotDog Temperature Management System of an electrically conductive blanket, both upper and lower body models, and a temperature control unit. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

We received responses from Ivona Domnisoru, Director of RA/QA, dated 09/27/2023 and 11/14/2023, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that is issued to your firm. We address these responses below, in relation to each of the noted violations.

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Translation

Our inspection revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:

1. Failure to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm identified the document titled “Vigilance and MDR Reporting Procedure”, Doc# D1041, Rev. N, dated 8/17/2023 as its written MDR procedure. After reviewing the procedure, the following deficiencies were noted:

a. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:
  i. The procedure includes the definition from 21 CFR 803.3 for the term “MDR reportable event”. However, the procedure omits definitions of the terms “become aware”, “caused or contributed”, “malfunction” and “serious injury” from 21 CFR Part 803.3, and the definition for the term “reasonably suggests” found in 21 CFR 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
  ii. The procedure, as written, combines language from the requirements of other regulatory or competent authorities with the requirements in 21 CFR Part 803 in a manner that will result in incomplete, inadequate, or even non-reporting of adverse events that meet the reportability requirements under 21 CFR Part 803.
  iii. The procedure does not include instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.

b. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the procedure does not include:
  i. Instructions for how to obtain and complete the FDA 3500A form.
  ii. The circumstance under which your firm must submit supplement or follow-up report and the requirements for such report.
  iii. A process for submitting initial and supplement or follow-up reports to FDA in an electronic format that FDA can process, review and archive in accordance with 21 CFR 803.12(a);
  iv. How your firm will ensure that all information reasonably known to you is submitted for each event. Specifically, which sections of the Form 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow-up within your firm.

c. The procedure does not describe how your firm will address documentation and record keeping requirements, as required by 21 CFR 803.17(b), including:
  i. Documentation of adverse event related information maintained as MDR event files.
  ii. Information that was evaluated to determine if an event was reportable.
  iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).

We reviewed your firm’s responses and concluded that they are not adequate because they do not address the above observation which we acknowledge was not included in the FDA Form 483.

Please note that your firm’s procedure includes references to baseline reports. According to Vol 73 Federal Register Notice 53686, dated September 17, 2008 (https://www.govinfo.gov/content/pkg/FR-2008-09-17/pdf/E8-21756.pdf), baseline reports are no longer required as of October 27, 2008 when FDA amended the Medical Device Reporting regulation to remove the requirement for baseline reports. Therefore, we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure.

2. Failure to submit an MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

Specifically, your firm failed to submit an MDR following the report from a healthcare facility of a second degree burn that was greater than 10 square inches requiring debridement and a skin graft. The information included for Complaint RMA #8000621601 reasonably suggests that the patient sustained blisters as a result of user error while using your firm’s warming mattress. The patient underwent debridement and skin grafting. Debridement and skin grafting is considered medical intervention necessitated to preclude permanent impairment of a body function or permanent damage to a body structure. As such, the injury represents a reportable serious injury as defined in 21 CFR 803.3 and an MDR should have been submitted to FDA. Your firm became aware of the event on December 2, 2020, and the FDA has not yet received an MDR for the referenced event.

We reviewed your firm’s responses and concluded that they are not adequate. The responses do not address why this injury was not reported to FDA as a MDR nor do they indicate that a MDR was submitted for this event. We acknowledge that the responses do not include information on MDRs since this observation was not included in the FDA Form 483.

Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

3. Failure to submit a Report of Correction or Removal of a device initiated to reduce a risk to health posed by the device, as required by 21 CFR Part 806.10.

Specifically, CAPA #22001 was initiated on 05/02/2022 following numerous customer complaints reporting EA POST (power-on self test) failure alarms for the WC77 Temperature Management Controller. EA POST failures can lead to procedure delays and the potential for patients to become or remain hypothermic. This CAPA was retroactively created to document corrective actions that were completed in 2021 which included a software update and the addition of (b)(4). Verification of effectiveness activities were conducted and CAPA #22001 was subsequently closed on 05/03/2022, the following day from its initiation. Root cause analysis, implementation of corrective actions, and associated verification of effectiveness activities were conducted outside of a CAPA system in real time and later documented following its completion. In addition, numerous customer complaints reporting EA POST failure alarms continue to be received following the implementation of the corrective actions. As a result of the customer complaints continuing to be received, CAPA #23001 was initiated on 07/13/2023 which was also created retroactively to document EA POST failure investigation work that started in February 2023. To implement corrective actions associated with these CAPAs, when customers experienced EA POST failures you authorized a return of their HotDog controllers and sent them controllers with the software update. You also sent customers (b)(4) for their devices to reduce EA POST failures caused by radiofrequency (RF) interference. These actions meet the definition of a medical device correction or removal initiated to reduce a risk to health or remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA.

We reviewed your firm’s response and concluded that it is not adequate to address the failure to submit a Report of Correction or Removal to FDA within 10 working days of initiating the medical device correction and removal actions. As of March 15, 2024, you have not submitted a Report of Correction or Removal to FDA.

It appears that your firm may have also replaced the controllers in devices for veterinary use. We recommend that you evaluate if this should have been reported to FDA as a veterinary product recall. In addition, CDRH recommends that your firm revise its Recall and Field Safety Corrective Action document following the definition of risk to health in 21 CFR 806.2(k), to support your reporting decisions for future medical device corrections or removals. In addition, in your response dated September 27 and November 14, 2023, you do not confirm that all affected devices subject to this error have been adequately corrected. Therefore, it is not clear if you track that the corrective action has been adequately implemented on all affected devices. Lastly, we recommend that you review your firm’s actions previously done outside of CAPA #22001 and 23001 and confirm that you have adequately corrected your procedures following the CAPA process going forward.

This inspection also revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

4. Failure to document the acceptance or rejection of incoming product, as required per 21 CFR 820.80(b). Specifically, multiple incoming component inspection records could not be located upon inspectional requests. For example, inspection records were not available for review for the following incoming components:

  a. Power Patient Warmer PCBA, part number (b)(4), under Purchase Order 70113463 indicating receipt of a quantity of (b)(4) units on (b)(4).
  b. (b)(4) Power Supply, part number (b)(4), under Purchase Order 70113139 indicating receipt of a quantity of (b)(4) units on (b)(4).
  c. Heating Element Fabric, part number (b)(4), under Purchase Order 70112458 indicating receipt of (b)(4) square yards on (b)(4)

We reviewed your firm’s response and concluded that it is not adequate. Your response does not address whether the inspection records were located or if the inspections were conducted. Please ensure you fully investigate this observation.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Melissa I. Michurski, Director of Compliance Branch, at oradevices2firmresponse@fda.hhs.gov. Refer to CMS # 671243 when replying. If you have any questions about the contents of this letter, please contact: Ashley Mutawakkil at (305) 816-1432 or Ashley.mutawakkil@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely yours,
/S/

Blake Bevill, M.S.
Program Division Director
Office of Medical Devices and Radiological Health
Operations Div. 2 Central

/S/

Bram Zuckerman, MD
Director
OHT 2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health