| Public Health Service Food and Drug Administration |
| Atlanta District Office 60 Eighth Street, NE Atlanta, GA 30309 |
Department of Health and Human ServicesApril 7, 2010
VIA FEDERAL EXPRESS
Donny C. Lambeth, President and CEO
Wake Forest University Baptist Medical Center
Medical Center Boulevard
Winston-Salem, North Carolina 27157
WARNING LEITER
(10-ATL-11)
Dear Mr. Lambeth:
During an inspection of your facility located in Winston-Salem, North Carolina on October 26, 2009 through November 19, 2009, an investigator from the United States Food and Dru Administration FDA) determined that your hospital utilizes the (b)(4) and (b)(4) devices. 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 any function of the body.
Our inspection revealed that your devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your Medical Center failed to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. We received your response dated November 23, 2009, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to Mr. Rich Lundy, Director, Cardiology Diagnostic Services. A copy of the FDA 483 is enclosed. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to submit a report on Form FDA 3500A or an electronic equivalent under 21 CFR 803.14 to FDA and/or the device manufacturer no more than 10 work days after becoming aware of information that reasonably suggests that a device has or may have caused or contributed to the death of a patient at your facility. [21 CFR 803.30(a)(1)]
For example, on (b)(4) patient (b)(4) died of internal hemorrhage from perforation of the right femoral artery after the (b)(4) vice was used on the patient at your facility.
We have reviewed your response and have concluded that it appears to be adequate because you have revised your Risk Management procedure (10/02/09).
The Risk Management section now includes provisions for collecting information related to the device and the adverse event, in order to determine whether the event should be reported on FDA Form 3500A. Section D (Reporting Criteria) provides a check box for determining whether a medical device has caused or contributed to a death, serious injury, or other adverse event or complication.
2. Failure to submit a report to FDA and/or the device manufacturer no more than 10 work days after becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury of a patient at your facility. [21 CFR 803.30(a)(2)).
For example, the following three serious injuries occurred at your facility. One of the serious injuries was not reported, and two serious injuries were not reported within the required 10 work day time frame. The injuries were as follows:
a) Following cardiac catheterization with an (b)(4) device on (b)(4) patient (b)(4) developed lower quadrant abdominal pain. Exploratory surgery revealed a hematoma with evidence of peritoneal perforation by the catheter. There is no documentation that an MDR report was filed with FDA or with the manufacturer.
b) Following cardiac catheterization with an (b)(4) device on (b)(4) patient (b)(4) as found to have bilateral retroperitoneal bleeding which required a blood transfusion. The device manufacturer was not notified of the event until (b)(4) 16 days later.
c) On (b)(4) patient (b)(4) experienced superficial esophageal lacerations from sharp protrusions at the tip of the esophageal probe. The FDA Form 3500 was not completed until (b)(4) 21 days later.
We have reviewed your response and have concluded that it appears to be adequate because you have revised your Risk Management procedure (10/02/09). Section 8, items 5-7, state that reportable MDR events will be forwarded to FDA no later than 10 working days after Wake Forest becomes aware of information that reasonably suggests that a medical device has caused or contributed to a an MDR reportable event. Your revised procedure also states that such reports will be sent to the manufacturer.
3. Failure to establish and maintain MDR event files which includes all documentation of deliberations and decision making processes used to determine if a device related death, serious injury, or malfunction was, or was not, reportable to FDA and/or the manufacturer. [21 CFR 803.18(b)(1)).
For example, at least eight vascular complications including, but not limited to, bleeding at the percutaneous access site, pseudoaneurysm, retroperitoneal bleed in access site occlusion and AV fistula occurred with the use of the (b)(4) devices between July 22, 2008 and June 5, 2009. There is no documentation in MDR event files of any deliberations and decision making processes used to determine if a device related death, serious injury, or malfunction was or was not reportable to FDA and/or the manufacturer.
We have reviewed your response dated November 23, 2009, and have concluded that it appears to be adequate because your revised procedure dated October 2009, now includes a decision making process for determining whether an adverse event is reportable or not. The procedure also provides for documentation of the adverse event in the case files by Risk Management.
4. Failure to develop, maintain, and implement written MDR procedures. [21 CFR 803.17(a)(2)].
For example, your procedure for risk management titled, "SUBJECT: SAFE MEDICAL DEVICES ACT OF 1990," does not provide for a standardized review process for determining when an event meets the criteria for MDR reporting.
We have reviewed your response and have concluded that it appears to be adequate because your revised procedure dated October 2009 now provides for an investigation of adverse events by Risk Management. If Risk Management and their consultant (b)(4) determine the event is reportable, such reports will be sent directly to FDA and/or the manufacturer.
5. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17(a)(3).
For example, your facility's procedure for risk management titled, "SUBJECT: SAFE MEDICAL DEVICES ACT OF 1990," does not include a requirement for the timely transmission of medical device reports to the manufacturer, to FDA, or to both, if required.
Your response dated November 23, 2009, is adequate because your revised procedure dated October 2009 now requires adverse events to be reported to FDA no later than 10 working days after the Medical Center becomes aware of information that reasonably suggests that a medical device has caused or contributed to an MDR reportable event. 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, 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.
Your response should be sent to: Serene N. Ackall, Compliance Officer, at the letterhead address. If you have any questions about the content of this letter please contact Ms. Ackall at 404- 253-1296.
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 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your hospital's 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 devices into compliance.
Sincerely,
/s/
John R. Gridley, Director
Atlanta District
Enclosure
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