|Subject:||Medical Device Reporting Regulation/Misbranded|
|Issuer:||Denver District Office|
|Issued:||Feb. 13, 2006||Closed:||
Department of Health and Human Services
Public Health Service
Denver District Office
February 13, 2006
VIA FEDERAL EXPRESS
Mr. Soren Mellstig
President and Chief Executive Officer
Stockholm, Sweden 10391
Mr. Nicholas Mendez
GAwLBRO Renal Products, Inc.
10810 W. Collins Avenue
Lakewood, CO 83215
Ref. # - DEN - 06-10
Dear Messrs. Mellstig and Mendez:
During an inspection of your establishment located in Lakewood, Colorado, between August 3 and September 1, 2005, our Investigator determined that your firm imports and distributes hemodialysis systems and accessories. The Prisma Continuous Fluid Management System and the Prismaflex System and accessories are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) 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 to affect the structure or any function of-the body.
The above-stated inspection revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your fm . failed or refused to furnish any material or information respecting the devices required by or under section 519, 21 U.S.C. 360i and Title 21, Code of Federal Regulations Part 803 (21 CFR 803) - Medical Device Reporting (MDR) regulation.
Significant deviations include, but are not limited to, the following:
1. Failure to submit MDRs to the Food and Drug Administration (FDA), with a copy to the manufacturer, within 30 calendar days of receiving or otherwise becoming aware of information that reasonably suggests that one of your marketed devices may have caused or
contributed to a death or serious injury, as required by 21 CFR 803.40(a). For example:
a. Complaint [redacted] (work order [redacted] )described an event that occurred on June 6, 2004, in which a patient died two days after the Prisma device in use removed an amount of fluid of 100cc more than it had been set to remove.
b. Complaint [redacted] (work order # [redacted] ) described an event that occurred on November 20, 2004, in which a facility reported that the Prisma device in use contributed to the death of the patient.
c. Complaint [redacted] (no work order number) described an event that occurred in December 2003, in which the Prisma device in use removed fluid from the patient when it had not been programmed to do so. The facility reported that the Prisma's "incorrect replacement weight change" alarm had been triggered and it could not be cleared.
d. Complaint [redacted] (work order [redacted] described an event that occurred on September 17, 2004, in which, over a three hour period of time, the Prisma device in use removed an amount of fluid of 100cc more than it had been set to remove (i.e. the device removed 334cc/hr when it had been set to remove 250cc/hr and it removed 329cc/hr when it had been set to remove 150cc/hr). The clinician decided to terminate the treatment. The patient had become hypotensive and required intravenous fluid administration.
e. Complaint [redacted] (no work order number) described an event that occurred on October 20, 2003, in which a facility reported that a critically ill patient almost died after his blood pressure dropped to 50. The facility reported that the Prisma device's "scale alarm" was triggered and after this happened, the machine was unable to continue providing treatment. As a result, the patient's blood pressure dropped and the patient required medical intervention.
Some additional examples of events that should have been reported as serious injuries are described in complaint [redacted] and [redacted]
2. Failure to submit ,MDRs to FDA, with a copy to the manufacturer, within 30 calendar days of
receiving or otherwise becoming aware of information that reasonably suggests that one of
your marketed devices has malfunctioned, and such device would be likely to cause or
contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR S03 .40(b). For example:
a. Complaint [redacted] (work order [redacted] described an event that occurred on October 22. 2003, in which the Prisma device in use removed excessive fluid from the patient. Specifically, the device had been set to remove 300m1/hr, but instead it removed 513mllhr during the first hour and 501m1/hr during the next hour.
b. Complaint [redacted] (work order described an event that occurred on July 23, 2003 . in which the Prisma device in use removed excessive fluid from the patient . Specifically, the device removed 200cc of patient fluid when it had been set at zero.
c. Complaint [redacted] (work order [redacted] ) described an event that occurred on June 4, 2003. in which, during a one-hour treatment, the Prisma device in use removed excessive fluid from the patient. Specifically, the device had been set to remove 170cc/hr, but instead it removed 490cc in one hour.
d. Complaint [redacted] (work order [redacted] described an event that occurred on May 20, 2004, in which a patient lost an unknown amount of blood due to a tear in the pump's blood tubing segment. Please note that a similar incident involving a hole in the pump's blood tubing occurred on May 17, 2004. In this case, the patient's blood pressure dropped and the patient was given one unit of blood. This incident was reported by [redacted] as a serious injury under [redacted]
e. Complaint [redacted] (work order [redacted] ) described an event that occurred on May 9, 2005, in which a patient lost an undetermined amount of blood due to a split in the pump's blood tubing segment.
With respect to deviations 1 and 2 described above, we are in receipt of your letter dated August 30, 2005, signed by Mr. Rod Rylands and addressed to Ms. Sharon Kapsch of our Center for Devices and Radiological Health, Office of Surveillance and Biometrics. Ms. Kapsch will respond to your correspondence under separate cover.
3. Failure to submit iv1DRs in accordance with 21 CFR 803 Subpart D - Importer Reporting Requirements. Under the MDR regulation, importers are required to submit a report of a device-related death or serious injury to FDA and the manufacturer within 30 days of becoming aware of such information. See 21 CFR 803.40(a). The regulation also requires importers to submit a report of a malfunction that would be likely to cause or contribute to a death or serious injury to the FDA and to the manufacturer within 30 days of becoming aware of such information. See 21 CFR 803.40(b). In accordance with 21 CFR 803.19(b), manufacturers and importers may submit a written request for an exemption or variance from any or all of the reporting requirements in the regulation. Thus, a manufacturer and importer can agree that only one report will be filed for a single event provided that FDA has granted a written request for an exemption or variance from the requirement that they both submit a report for the same event. In that case, the report should contain information on both firms.
During the inspection of your facility, our investigators collected information on [redacted] events for which the manufacturer, [redacted] had submitted MDRs, including [redacted] . However, your firm had not submitted MDRs for these events, as required by Subpart D of the MDR regulation.In accordance with 21 CFR 803.17(a)(2) and (3), your firm must maintain, among other things, written MDR procedures for internal systems that provide for timely communication of events that may be subject to the reporting requirements. This would include documenting the agreement between your firm and [redacted] to submit only one MDR for the same event and reflecting the agreement in your firm's procedures. Please note that we do not expect your firm to submit MDRs or supplements for the above referenced [redacted] MDRs. However, we do expect both firms to be;in reporting this way from the date of this letter until you have obtained an exemption or variance from the reporting requirements, indicating that it is sufficient for the two companies to submit only one MDR for an event.
In regard to [redacted] Procedure Number collected during this inspection, we would like to point out the following:
a. Page [redacted] of this procedure is incorrect when it states: [redacted] because the importer obligation does apply to GRP. However, the firm can request written authorization from the Office of Surveillance and Biometrics (OSB), for single event reporting to cover both importer and manufacturer MDR reporting. The manufacturer can prepare the MDRs with information on the Importer entered in section F of the MDR 3500A form.
b. Page [redacted] of this procedure is incorrect when it states that [redacted] because separate malfunction reports should be completed for each identified incident. See 21 CFR 803.42(c)(6).
c. There is a concern regarding the instruction found in [redacted] of this procedure, which states that if the product [redacted] . We are concerned because this sample might need to be examined at the facility prior to its [redacted] to determine why it failed.
We are in receipt of correspondence dated September 16, 2005, and October 7, 2005, submitted in response to the FDA 483 issued at the end of the August - September 2005 inspection of your facility. We are also in receipt of progress reports dated October 31, 2005, and November 30, 2005, signed by Mr. Rod J. Rylands. We have the following comments regarding these responses:
Concerning your firm's response to Observation 6, your October 31 progress report stated that your firm has reviewed all complaints concerning the Prisma device since 2002 , [redacted] related to the [redacted] to determine if they should have been reported as MDRs. As a result, you have filed [redacted] retrospective MDRs. Your reasoning for not including complaints related to the [redacted] , was that these problems have already been addressed in the [redacted] . This response is inadequate because, although the [redacted] was created to address the [redacted] problem, it does not exempt you from submitting MDRs for events related to this issue. Additionally, your September 16 response to the FDA 483 stated that your firm would re-review the complaints noted in Observation 6 of the FDA 483 and determine whether the complaints described events that should have been reported as MDRs. In follow-up to that correspondence, your firm's October 7 response indicated that a [redacted] had reviewed the complaints and concluded that the Prisma did not cause or contribute to the deaths and serious injuries described in the complaint records. The October 7 response also stated that the medical review document containing these conclusions would be included as part of the appropriate complaint tiles. However, a copy of this document was not included as part of your response. Please provide a copy of this document for our review.
In regard to your firm's response to Observation 7, your September 16 response stated that GAVIBRO Renal Products was to review its policies and procedures with regard to submitting an NLDR where user error caused or contributed to an unexpected fluid loss or gain. Your September 16 response also indicated that you would contact OSB to schedule a meeting where you could discuss this matter in further detail. This response is inadequate because, as of this date, your firm has not submitted any additional information regarding the status of your review and/or the results of the meeting with OSB. Please provide us with an update on the status of your review.
In regard to your firm's response to Observations 8 and 10, your September 16 response stated that the service technicians are trained to conduct quality screenings by answering the following [redacted] questions, [redacted] .This response implies that if the technician answers [redacted] either of the first [redacted] questions, the service report is routed and subsequently handled as a potential MDR. However, our review of the service reports indicates otherwise. For instance, many of the event descriptions found in some of the service reports reviewed are similar to the event descriptions found in other service reports that have been handled as complaints and MDRs in the past. It is unclear why these service reports were also not handled as complaints and/or MDRs. Please review your service reports and provide a justification why these similar service reports were not handled as complaints and/or MDRs.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is you responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection (a copy of which is included for your information) may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
Federal agencies are advised of the issuance of all Warning, Letters about devices so that they may consider this information when considering the award of contracts. No requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations 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.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the additional steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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 reply should be sent to the Food and Drug Administration, Denver District Office, P. 0. Box 25087, Denver, CO 80225-0087, Attention : Regina A. Barrell, Compliance Officer. If you have any further questions, please feel free to contact Ms. Barrell at (303) 236-3043.
B. Belinda Collins