| Public Health Service Food and Drug Administration |
Denver District Office |
Department of Health and Human Services
November 22, 2010
WARNING LETTER
VIA UPS
Mr. Lee Travis
Principal Owner
WalkMed Infusion, LLC
96 Inverness Dr. East, Suite J
Englewood, CO 80112
Ref # DEN-11-02
Dear Mr. Travis:
During an inspection of your firm located at 96 Inverness Drive East, Suite J, Englewood, Colorado, on September 7 – 16, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II electronic infusion pump systems (ambulatory and pole mount), including reservoir bags and administration sets. 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 are intended to affect the structure or function of the body.
This inspection 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. You can find these regulations on the FDA website at www.fda.gov
Significant deviations include, but are not limited to, the following:
1. You have failed to review, evaluate and investigate all complaints involving the possible failure of a device, 21 C.F.R. 820.198(c).
Specifically:
• (b)(4) complaints reviewed by our investigator related to severe under-delivery of infusion fluid. However, you did not conduct investigations of these complaints to determine if medical intervention was required and the ultimate patient outcome in order to make appropriate MDR reportability determinations.
• In addition, in (b)(4) complaints involving alarm failures, your Complaint Questionnaire was missing pertinent information. However, it appears that no attempt was made to obtain this information in order to accurately assess the potential for patient injury.
We acknowledge receipt of your September 30, 2010 letter responding to our Inspectional Observations, Form FDA 483 dated September 16, 2010. Your response is inadequate in that although you reported making changes to your Complaint Handling Procedure (b)(4), you did not provide a copy of this revised procedure for our evaluation.
2. You have failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, 21 C.F.R. 820.30(a).
Specifically:
• Your Design Control Procedure (b)(4) has not been implemented, in that the Triton Pump System Verification & Validation (b)(4) does not document that the design validation included testing of production units under actual or simulated use conditions, as required by 21 C.F.R. 820.30(g).
• In addition, the Design Input for Triton Infusion Pump (b)(4) contains no inputs for the WalkMed Infusion administration sets which are to be used with the infusion pumps, as required by 21 C.F.R. 820.30(c).
• Because you did not include administration set inputs in your Triton Infusion Pump design verification/validation, your Triton Infusion Pump Risk Analysis/Failure Modes and Criticality Analysis, document (b)(4) is incomplete in that you failed to identify and evaluate potential hazards involved with use of the administration sets, such as, sub-component and connector failures and non-sterility, 21 C.F.R. 820.30(g).
• Your Triton Infusion Pump Risk Analysis/Failure Modes and Criticality, document (b)(4) is further inadequate in that it determined that over infusions would always be detected, when in fact the failure of the Door Open Alarm resulted in over infusions, causing your firm to conduct a product recall.
• Your Risk Management procedure, document (b)(4), requires that device risk analysis be revised to incorporate newly identified hazards. However, you failed to revise the WalkMed Infusion Pump System risk Analysis, document (b)(4) after receiving at least (b)(4) complaints of severe under-infusion when patients were using the pumps at home.
Your September 30, 2010 letter, responding to our Inspectional Observations Form FDA 483 and addressing these items, is further inadequate in that although you stated you had revised your Triton Pump design and risk assessment documents, and will conduct user testing; you did not provide the revised documents for our evaluation, and the user testing will not be completed for (b)(4).
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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 award of contracts.
Additionally, premarket approval applications for devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
As stated in your September 30, 2010 letter, we acknowledge that you submitted to this office documentation of the Triton Pole Mount Infusion Pump recall you initiated June 17, 2010, as required by 21 C.F.R. 806.10(a)(1). We wish to remind you that reports of corrections or removals of this type are to be submitted to FDA within 10 days of initiating such correction or removal, 21 C.F.R. 806.10(b). Your response regarding this issue is inadequate in that you did not provide a copy of your updated Field Action and Recall Procedure, document (b)(4), for our evaluation.
We also acknowledge, as stated in your September 30, 2010 letter, that you faxed to FDA the MDR report for complaint (b)(4) dated January 13, 2009 on September 16, 2010. However, 12 C.F.R. 803.50((a) requires that, if you are a manufacturer, you must report to FDA no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market: 1. May have caused or contributed to a death or serious injury; or 2. Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Your response to this item is inadequate because you did not provide a copy of your revised Potential Hazard and Possible Resultant Harm section of your Risk Analysis WalkMed System, document (b)(4) for our evaluation.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of any additional steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Your response should be sent to: Food and Drug Administration, Denver District, P. O. Box 25087, Denver, CO 80225-0087, Attention: William H. Sherer, Compliance Officer. If you have any questions, please contact Mr. Sherer at (303) 236-3051.
Sincerely,
/s/
H. Thomas Warwick
Denver District Director
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