| Public Health Service Food and Drug Administration |
| Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
Department of Health and Human ServicesJuly 29, 2010
Ref: 2010-DAL-WL-13
WARNING LETTER
CERTIFIED MAIL
RETURNED RECEIPT REQUESTED
Mr. Jeremy Kraus
President and General Manager
HSMG, Inc. dba Smartlnfuser USA
8588 Katy Freeway Suite 348
Houston, Texas 77024
Dear Mr. Kraus:
During an inspection of your firm located in Houston, Texas on November 17, 2009 through December 18, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports the Smartlnfuser PainPump™, SmartBlock™ PainPump, and accessories. 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 your above-referenced devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and Title 21 Code of Federal Regulations (CFR) Part 803 - Medical Device Reporting (MDR) regulation.
We received a response from you dated January 13, 2010, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response 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 to the FDA, as soon as practicable but no later than 30 calendar days after becoming aware that one of your marketed devices may have caused or contributed to a death or serious injury, as required by 21 C.F.R. § 803.40(a). For example:
a. Your firm failed to submit an MDR report to FDA about an "overdose incident" that occurred in (b)(4) on January 16, 2009. Your firm became aware that the patient was over-infused with a pain medication over a short period of time while the device was on a fast prime function. The patient went later to a hospital's emergency room for medical treatment. Your firm reported that the device appeared to be on the prime position. Although the foreign manufacturer submitted to FDA an initial MDR report on May 7, 2009, and a supplement report on August 13, 2009, your firm, as an importer of the marketed device, should have reported the medical adverse event as an MDR on Form 3500A to the FDA, with a copy to the manufacturer, no later than February 17, 2009.
b. Your firm also failed to submit an MDR report to FDA for an "excessive infusion" incident that occurred at a hospital in (b)(4) on January 22, 2008. The patient was in a recovery room with a Smartlnfuser pain pump attached and had seizures. Your firm's incident report, dated January 22, 2008, states that you became aware that the patient had been over-infused with a pain medication in a short time due to a pump dispensing from the prime position. You stated to our investigator that the medical adverse event was due to user error. Your firm, as an importer of the marketed device, should have reported the medical adverse event as an MDR on Form 3500A to the FDA, with a copy to the manufacturer, no later than February 23, 2008. At the conclusion of the inspection on December 18, 2009, your firm had still not reported this medical adverse event to FDA.
2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. § 803.17. For example:
Your firm did not establish a written procedure to address the following: 1) documentation and recordkeeping requirements for handling and processing information on MDR reportable events, 2) for submitting complete and timely reports to FDA, and 3) for maintaining MDR event files and distinguishing them from other complaint records. Review of your firm's complaints revealed reports from the field involving patients and, therefore, potential health risks. During the inspection you acknowledged that your firm did not have written procedures for reporting individual events, investigating problems, and maintaining MDR files. Your firm did not appear to be knowledgeable about FDA's importer reporting requirements.
We have reviewed your response and have concluded that it is inadequate because you promised to correct all shortcomings but did not provide specific corrective actions for resolving this observation.
Our inspection revealed that your above-referenced devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 - Reports of Corrections and Removals regulation. Significant deviations include, but are not limited to, the following:
1. Failure to submit a written report to FDA of any correction or removal of a device initiated to reduce a risk to health posed by the device, as required by 21 C.F.R. § 806.10(a)(1). For example:
Your firm failed to report to the Dallas District Office about a voluntary general recall of all Smartlnfuser™ PainPump and SmartBlock™ PainPump initiated on January 22, 2009. Your firm recalled these products because you received a report of over infusion of pain medication due to the user's incorrect use of the pain pump's fast priming feature on January 16, 2009. On January 22, 2008, your firm also received a similar report related to a patient overdose incident. In order to prevent serious injury or death to patients, your firm decided to remove these pain pumps from the market until you could provide adequate training to all dealers and sales agents, to ensure the appropriate use of the current fast priming feature. Your firm also received (16) reports of leaks in the pain pumps because of bonding defects. Leaks during patient usage can cause insufficient pain therapy and medical intervention.
We have reviewed your response and have concluded that it is inadequate because you promised to correct all shortcomings but did not provide specific corrective actions for resolving this observation.
This inspection also revealed that your firm is not registered with the FDA as a medical device initial importer. You must appropriately register your establishment as an initial importer of medical devices with the FDA. Failure to register as a device initial importer is a violation of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360. Information on how to register can be found at http://www.fda.gov/cdrh/devadvice/3122.html.
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 Class III devices to which the Quality System regulation (21 C.F.R. Part 820) 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.
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. You should 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.
During this inspection the FDA noted some nonconformities which are deficiencies of the Quality System (QS) regulation found at 21 C.F.R. Part 820. These problems were reported to you and formally discussed with your firm's management. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. § 820.198(a). For example:
a. Your firm did not have a written complaint handling procedure for handling initial complaints and appropriate follow up, including Medical Device Reporting and corrective actions. You initially stated that your firm did not receive any complaints, but subsequently stated that incident reports from the field were kept electronically for business purposes. You stated that you had filed/labeled the incidents by Calendar (b)(4) since December 31, 2008 (b)(4) and (b)(4) to date), and by (b)(4) You also stated that the incident reports were labeled with a descriptive title and the date created. Your firm did not record complaints by number or in a complaint notification/incident report form to ensure that all information required by 21 C.F.R. Part 820.198 is documented and filed together.
b. You stated that the incident reports were typically leak issues. The inspection revealed that your firm had received approximately sixty (60) incidents since July 2007. Sixteen (16) incidents were related to leaks in the devices during patient use, and two (2) incidents involved over-infusion of pain medication. Your firm has not investigated these complaints as required by the Quality System regulation.
c. Your firm did not obtain and document the investigation details related to a product incident/return from a distributor. The distributor's RGA (return good authorization) form alleged that a pain pump from Lot #9009 was leaking from the reservoir and that the priming position of the regulator could not be locked to prevent "fast priming." Your firm could not confirm the leak, but confirmed that the "fast priming" was due to potential user error. Your firm contacted the foreign manufacturer to report the problems. Your firm and the foreign manufacturer agreed to retrieve (b)(4) pain pumps of Lot #9009 from the distributor. The foreign manufacturer requested from your firm (b)(4) new pain pumps from the lot remaining in inventory. The (b)(4) pumps were going to be used to help complete the investigation of the problems and to re-train the customer on how to safely use the pain pump regulator, as recommended by the manufacturer. Your firm could not provide evidence to demonstrate: that the (b)(4)new pain pumps were sent to the foreign manufacturer for testing; that the distributor returned the (b)(4) recalled pain pumps; and that your firm sent product replacements.
We have reviewed your response and have concluded that it is inadequate because you promised to correct all shortcomings but did not provide specific corrective actions for resolving this observation.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
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 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.
Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director
No comments:
Post a Comment