Inspections, Compliance, Enforcement, and Criminal Investigations

ArjoHuntleigh Inc. 9/18/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

September 18, 2014
 
2014-DAL-WL-19
WARNING LETTER
 
VIA UNITED PARCEL SERVICE
 
Ms. Yvonne McMann
Product Compliance Director
ArjoHuntleigh, Inc.
12625 Wetmore Road, Suite 308
San Antonio, TX 78247
 
Dear Ms. McMann:
 
During an inspection of your firm located at 6203 Farinon Dr, San Antonio, TX 78249on July 24, 2013, through August 2, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System.  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.
 
As of September 18, 2014, FDA reviewed your marketing materials and determined that the RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed.  The RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction these devices into interstate commerce for commercial distribution these devices, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 890.5225, Powered Patient Rotation Bed,without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii). 
 
Devices classified under 21 CFR 890.5225, Powered Patient Rotation Bed, are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). However, there is evidence that the RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5225, Powered Patient Rotation Bed. Generic devices of this type are intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation. However, your firm is marketing the RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System for different intended uses, namely the prevention and treatment of the pulmonary consequences of immobility such as Acute Respiratory Distress Syndrome (ARDS) and Ventilator-Associated Pneumonia (VAP) while maintaining skin integrity for the critically ill patient. Additional claims reference infection-related ventilator associated complication (IVAC).  The following website claims were observed at www.arjohuntleigh.us and www.arjohuntleigh.com.
 
Your firm’s website states for all systems:
 
  • “From ARDS to IVAC, ArjoHuntleigh products such as the RotoProne Therapy System and the TriaDyne Proventa Therapy System deliver clinically proven results…”
 
Your firm’s website states for the RotoRest Delta Therapy System:
 
  • “Advanced kinetic therapy…for aggressive treatment of pulmonary complications.”
  • “The RotoRest Delta Kinetic Therapy System offers features and benefits designed to help aggressively treat patients with severe pulmonary complications such as VAP and ARDS…”
  • “Treatment and prevention of pulmonary complications associated with immobility.”
  • “Advanced kinetic therapy…has been clinically demonstrated to improve oxygen and reduce the risk of VAP”
 
Your website states for the TriaDyne Proventa System:
 
  • “Treatment and prevention of pulmonary complications associated with immobility.”
  • “The TriaDyne Proventa Therapy System provides multiple therapies for pulmonary and skin care.”
  • “Kinetic therapyTM - bilateral rotation of patients 40° or more – increases oxygenation and reduces risk of ICU-acquired pneumonia”
 
Your website states for the RotoProne Therapy System:
 
  • “The RotoProne Therapy System offers features and benefits designed to help aggressively treat patients with severe pulmonary complication such as VAP and ARDS.”
  • “Prone therapy: Has been clinically demonstrated to help improve oxygenation1,2, and protect against ventilator induced lung injury1.”
  • “Kinetic Therapy: Advanced kinetic therapy (bilateral rotation up to 62 degrees) has been clinically demonstrated to reduce the risk of VAP.”
 
Your RotoRest Delta Therapy System sales sheet states:
 
  • “50% reduction in nosocomial pneumonia”
  • “Over 50 clinical studies have demonstrated that this therapy prevents and treats pulmonary complications.”
  • “Indications
    • Treatment and prevention of pulmonary complications associated with immobility
    • Thoracic or lumbar fracture
    • Skeletal traction
    • Cervical traction”
 
Your RotoRest Delta Advanced Kinetic Therapy System User Manual states:
 
  • “The RotoRest Delta Advanced Kinetic Therapy System offers Advanced Kinetic Therapy for the most aggressive treatment of pulmonary complications.”
  • “Kinetic Therapy can help resolve atelectasis and reduce the incidence of nosocomial pneumonia.”
  • “RotoRestSystem is indicated for treatment and prevention of pulmonary complications as a result of immobility and maybe suitable for adult patients with:
    • Thoracic fracture
    • Lumbar fracture
    • Cervical or skeletal traction following primary stabilization”
 
Your RotoRest Advanced Kinetic Therapy System Quick Reference Guide states:
 
  • “The RotoRest Delta Advanced Kinetic TherapySystem offers Advanced Kinetic Therapy for the most aggressive treatment of pulmonary complications.”
  • “RotoRestSystem is indicated for treatment and prevention of pulmonary complications as a result of immobility and maybe suitable for adult patients with:
    • Thoracic fracture
    • Lumbar fracture
    • Cervical or skeletal traction following primary stabilization”
 
Because there is evidence that the RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5225,it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.  
 
Our inspection also revealed that RotoRest Delta Therapy System, the RotoProne Therapy System, and the TriaDyne Therapy System are misbranded under section 502(t)(2) of the Act 21 USC 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
For example, after reviewing your firm’s MDR procedure titled “QP-21-01-AH, Global Adverse Event and Incident Reporting Process” dated 7/22/2013, the following issues were noted:
 
1.    QP-21-01-AH does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
 
a.    Instructions for how to obtain and complete the FDA 3500A form.
b.    The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
 
2.    QP-21-01-AH does not describe how your firm will address documentation and record-keeping requirements, including:
 
a.    Documentation of adverse event related information maintained as MDR event files.
b.    Information that was evaluated to determine if an event was reportable.
c.    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.
d.    Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations 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.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.  
 
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 correct 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 (including any systemic corrective actions) 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 all violations included in this Warning Letter.
 
Your firm’s response should be sent to: Dallas District Office, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have any questions about the contents of this letter, please contact: Jeff R. Wooley at 214-253-5251.
 
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 the violations, and take prompt actions to correct the violations and bring the products into compliance. 
 
 
Sincerely,
/S/                                                           
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 
CC:
 
Harald Stock
President and CEO
ArjoHuntleigh, Inc.
Neptunigatan 1
SE-211 20
Malmo, Sweden
 
Lena Hagman, VP Global Innovation
ArjoHuntleigh, Inc.
Neptunigatan 1
SE-211 20
Malmo, Sweden
 
Rick Lytle, President North America
ArjoHuntleigh, Inc.
2349 W. Lake Street, Suite 250
Addison, IL 60101

Page Last Updated: 07/27/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English