Inspections, Compliance, Enforcement, and Criminal Investigations
CardioCommand, Inc. 13-Aug-03
Public Health Service
|555 Windertey PI., Ste. 200
Maitland, FL 32751
RETURN RECEIPT REQUESTED
August 13, 2003
Dr. Maynard Ramsey
President & CEO
4920 W. Cypress Street
Tampa, Florida 33607
Dear Dr. Ramsey
During an inspection of your establishment located in Tampa, Florida on March 5 - 10, 2003, Investigator R. Kevin Vogel determined that your establishment manufactures the Taptest Transesophageal Atrial Pacing System, the Taptest Model 3 Preamplifier, the Tapscope Model 210/210S Cardiac Pacing and Recording Catheter, the Tapcath Model 205 Pacing and Recording Esophageal Catheter, the Tapsystem 2A Pulse Esophageal Generator and the Tapscope Model 550 Cardiac Pacing and Recording Stethoscope. These products are intended for use by physicians to pace and control heart rate and cardiac output and are devices, as defined by
Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act, 21 U.S.C.321(h).
Quality System Regulation
The inspection revealed that the Esophageal Pacing and Recording Systems are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packaging, storage, or installation are not in conformance with the Quality System (QS) Regulation for medical devices, as specified in Title 21 Code of Federal Regulations (CFR), Part 820 because of the following observations.
1. Your firm failed to establish procedures for quality audits and to conduct such audits to assure that your quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, during the inspection our investigator found quality system violations, including but not limited to MDR deviations, failure to submit appropriate PMA supplements for manufacturing site changes, inadequate purchasing control, and
inadequate process validation that were not detected by your quality audits (FDA 483, Item #9).
2. Your firm failed to establish and maintain procedures for implementing corrective and preventive action including requirements for identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems, as
required by 21 CFR 820.100(a)(3). Specifically, you failed to take timely preventive action covering the Tapsystem Model 2A Esophageal Pulse Generator devices, which have not received the upgrade for EM1 resistance and are still in use in the field. This
defect was reported in Product Complaint #960020 dated September 16, 1996, referencing a patient whose heart rate dropped requiring medical intervention after the unit was affected by external EM1 from an electrosurgical device. At the time of this
inspection [redacted] Model 2A devices remain in service and have never been updated (FDA 483, Item #1).
3. Your firm failed to establish and maintain procedures for implementing corrective and preventive action, including requirements for verifying or validating the corrective or preventive action to ensure that such action is effective and does not adversely affect the
finished device, as required by 21 CFR 820.100(a)(4). (FDA 483, Item #10).
4. Your firm failed to validate with a high degree of assurance and approve according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test, and to document the validation activities and results, as required by 21 CFR 820.75(a). Specifically, there is no record of validation documenting the spot welding done on Tapcath Model 205 and Tapscope 210/210S Cardiac Pacing and Recording Catheters including strength test, and validation of the crimping of electrodes
on catheters was inadequate because three separate runs were not documented to demonstrate the consistency and effectiveness of the process (FDA 483, Item #5).
5. Your firm failed to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm failed to assure that appropriate and validated
ESD reduction procedure devices manufactured by continue to be distributed board assembly of the Taptest Models 7N3A These devices were received in 1994 and devices manufactured by [redacted]. In addition, your firm failed to assure that a supplier of tubing used in the manufacture of Tapcath Model 205 and Tapscope Models 210/210S Cardiac Pacing and Recording Catheters validated its extrusion process. (FDA 483, Item #4).
6. Your firm failed to document and review periodic inspections of environmental control systems as required by 21 CFR 820.70(c). Specifically, there is no documentation of semiannual testing required in the ESD procedure for wrist straps and mats used by the
firms service personnel (FDA 483, Item #6).
7. Your firm failed to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, you failed to follow your own design control procedures when a switch protector was added to the Tapsystem Model 2A Esophageal Pulse Generator in March of 1998 (FDA 483, Item #7).
8. Your firm failed to have a formally designated unit maintain a record of an investigation under 21 CFR 820.198, as required by 21 CFR 820.198(e)(5). Specifically, you failed to obtain information to determine MDR reportability covering product complaints, e.g.,
Complaint #970020 dated September 5, 1997 (FDA 483, Item #8).
Medical Device Reporting (MDR)
The inspection revealed that the Esophageal Pacing and Recording Systems are misbranded with the meaning of Section 502(t)(2) of the Act, in that your firm failed to submit information to the Food and Drug Administration (FDA), as required by 21 CFR 803, the Medical Device Reporting (MDR) regulation, Specifically, your firm failed to submit information to the FDA as required by the MDR regulation for:
Product Complaint #960020
This complaint involves a surgical procedure on a 70 year old patient where the model 2A went crazy, the patients heart rate dropped to 30 bpm, almost put her in cardiac standstill and required drug management (atropine) to increase the patients heart rate. This incident meets the definition of a serious injury, as described in 21 CFR 803.3(bb)(1) and, consequently should have been reported as a serious injury in accordance with the provisions 21 CFR Part 803.
In addition, you have not submitted a PMA supplement to PMA P860008 (Cardiac Pacing and Recording Catheters Tapscope Model 210/210S) for the manufacturing location at [redacted]. In accordance with 21 CFR 814.39(a)(3), a t facility or establishment is to be used to manufacture, process, or package a device, when such a change affects the safety or effectiveness of the device. FDA believes this change would affect the safety or effectiveness of this device and, consequently, a PMA supplement is required.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each applicable requirement of the Act and FDA regulations. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the awards of contracts.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Additionally, no premarket submissions for Class III devices to which QS regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certification for Products for Export will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen ( 15) working days of receipt of this letter the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. Your response should be sent to Timothy J. Couzins, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4728.
Kendall W. Lester for Emma Singleton
Director, Florida District