Inspections, Compliance, Enforcement, and Criminal Investigations

Maquet Cardiopulmonary Ag 12/4/14

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire A venue
Silver Spring, MD 20993 

DEC 4, 2014

Warning Letter
 
Via United Parcel Service
 
Mr. Harmut Schmidt
President
Maquet Cardiovascular AG
Kehler Strasse 31
D-76437 Rastatt
Germany
 
Re: CardioHelp System
Refer to CMS # 438658
 
Dear Mr. Schmidt:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the CardioHelp System in the United States without the necessary marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Under section 201(h) of the Act, 21 U.S.C. § 321(h), the CardioHelp System is a device because it is 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.
 
The FDA has reviewed your firm’s websites (www.maquet.com and www.cardiohelp-us.com) and determined that certain claims on those websites have caused the CardioHelp System to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have, for the particular uses described below, 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The CardioHelp System is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered into interstate commerce for commercial distribution a device with major changes/modifications to the intended use without submitting a new premarket notification to the agency as required by 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii).
 
Specifically, the CardioHelp System was cleared under K102726 and K133598 (modification to K102726) with the following intended uses:
 
The CardioHelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours).  It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
 
The CardioHelp System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g., for intra- and inter-hospital transport.
 
The CardioHelp System in configuration with the QUADROX iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods up to six hours).
 
However, your firm’s promotion of the device provides evidence of major changes/modifications to the device’s intended use, for which your firm lacks the required FDA clearance and/or approval.
 
Specifically, FDA has reviewed your firm’s website (www.maquet.com), which contained a marketing brochure for the CardioHelp System titled, CardioHelp System, Designed to Save Lives. This marketing brochure includes the following statements about the CardioHelp System:
 
The CARDIOHELP System is the world’s smallest portable heart-lung support system. It is ideal for use in critical care, cardiac catheterization laboratories . . . and trauma rooms.
  • Critical Care Medicine: In cases of respiratory failure, the CARDIOHELP System provides oxygen supply and carbon dioxide removal.  Further areas that may require support include:
o   Acute Respiratory Distress Syndrome (ARDS)
o   Septic Shock
  • Cardiology: In the event of cardiogenic shock, a frequent consequence of heart attack, it may be crucial to provide circulatory support as quick as possible. The CARDIOHELP System can protect against organ damage by preventing insufficient supply to vital organs.  Areas of application may include:
o   Cardiogenic shock
o   As stand-by prophylactic support during high risk PCI
o   Myocarditis
 
Additionally, FDA’s review of your firm’s website (www.maquet.com) revealed a marketing brochure entitled, CardioHelp Therapy Guide, Expand Your Therapy Options.  This marketing brochure includes claims and/or statements that the CardioHelp System can be used in the following manner: 
  • Respiratory Assist: Veno-venous ECLS
o   Place: Critical Care
o   Possible diseases: respiratory failure without cardiac impairment
o   Fields of application: respiratory failure without cardiac impairment
o   CARDIOHELP thApp: v-v ECLS
  • Circulatory and Respiratory Assist: Veno-Arterial ECLS
o   Place: Critical Care, Cath Lab, ER, OR
o   Possible diseases: Respiratory and circulatory failure
o   Fields of application: heart and lung failure
o   CARDIOHELP thApp: v-a ECLS
  • Staged Therapy/Combined Therapy
 
The CardioHelp System was cleared for providing circulatory and/or pulmonary support for up to 6 hours during procedures (including surgical procedures requiring cardiopulmonary bypass) and during inter or intra-hospital transport.  The CardioHelp System was not cleared for use as a medium or long-term therapeutic assist or support system for ongoing refractory circulatory and/or respiratory failure of various etiologies.
 
Moreover, the CardioHelp System has only been indicated for use during procedures or transport less than or equal to 6 hours in duration. However, the uses above represent acute and/or chronic pathologic conditions that result in significant impairments in heart and/or lung function that are so severe that those organs can no longer serve their primary functions, and as such, require medium or long-term circulatory and pulmonary assistance or support (i.e., Extracorporeal Membrane Oxygenation). Clinical resolution of the underlying conditions, such as those listed above, sufficient to allow resumption of normal life-sustaining organ function and circulation, whether it affects the heart and/or lungs either primarily or secondarily, would be clinically anticipated to require greater than 6 hours of support.
 
As such, the above claims constitute major changes or modifications to the CardioHelp System’s cleared intended uses, for which your firm lacks clearance or approval.  
 
For devices requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency.  21 CFR 807.81(b).  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Our office requests that Maquet Cardiovascular AG immediately cease activities that result in the misbranding or adulteration of the CardioHelp System as listed above, such as the commercial distribution of the device for the uses discussed above.
 
Maquet Cardiovascular AG should take prompt action to correct the violations addressed in this letter.  U.S. 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 (which must address systemic problems) 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.
 
In addition to the violations described above, FDA notes that your firm markets the CardioHelp System with indications that may also require medium or long-term circulatory and pulmonary assistance or support.  Specifically, your firm’s brochure entitled, CardioHelp System, Designed to Save Lives, contains claims, phrases, or statements that indicatethat the CardioHelp System may be used in medical emergencies to restore and stabilize the patient’s cardiopulmonary function during cardiopulmonary resuscitation.  Such conditions include, but are not limited to, anaphylactic shock, trauma and hypothermia.  These conditions often require therapeutic support in excess of 6 hours and may also raise new questions of safety and effectiveness that could require either premarket approval and/or clearance.  Please provide us with the basis for marketing the CardioHelp System with these claims and/or statements, and a statement regarding whether your firm intends to continue making such claims. 
 
Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CMS # 438658 when replying. We remind you that only written communication is considered as official.  If you have any questions about the contents of this letter, please contact: LaShanda M. Long, Chief, Surveillance and Enforcement Branch 1, at (301) 796-5465 or via fax at (301) 847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
Sincerely yours,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
      Radiological Health
 
cc:      
Mr. Raoul Quintero
President and Chief Executive Officer
Maquet Cardiovascular, L.L.C.
45 Barbour Pond
Wayne, NJ 07470

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