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Smiths Medical ASD Inc. MARCS-CMS 617147 —

Delivery Method:
VIA Electronic Mail
Medical Devices

Recipient Name
JehanZeb Noor
Recipient Title
Smiths Medical ASD Inc.

6000 Nathan Lane N.
Minneapolis, MN 55442
United States

Issuing Office:
Center for Devices and Radiological Health

United States

CMS # 617147

October 1, 2021

Dear Mr. Noor:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Smiths Medical ASD, Inc., located at 6000 Nathan Lane N. Minneapolis, Minnesota, from February 23 – March 30, 2021 with an amended 483 signed May 28, 2021. During the inspection, FDA investigators determined that your firm is a specification developer and manufacturer for a variety of medical devices including blood warmers and infusion pumps. 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 to affect the structure or any function of the body.

Our inspection revealed that your firm’s 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 Parts 803 and 806 - Medical Device Reporting and Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

1. Failure to submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).

For example, the information included in Complaint CC-0094982 and Complaint CC-0099632 reasonably suggests that your firm’s Medfusion Syringe Pump malfunctioned (i.e., unexpected battery depletion) while in use. Your firm initiated a recall Z-0610-2020 for the referenced malfunction. Per the Preamble, in the Medical Devices; Medical User Facility and Manufacturer Reporting, Certification and Registration; Final Rule, 60 Fed. Reg. 63585 (Dec. 11, 1995), Comment 12, a malfunction is reportable if the manufacturer takes or would be required to take an action under sections 518 or 519(g) of the act as a result of the malfunction of the device or other similar devices. As such, the referenced complaints meet the definition of a reportable malfunction, as defined in 21 CFR 803.3. There is no information included for the complaints that rules out that the device may not have caused or contributed to the referenced malfunctions. As such, your firm failed to submit an MDR for each of the referenced complaints.

Your firm’s responses dated May 20, 2021, June 25, 2021, June 29, 2021, and July 28, 2021 were reviewed and determined to be inadequate. The responses noted that your firm initiated systemic corrections and corrective actions, such as a root-cause investigation and plan to improve MDR reporting process. However, your firm did not provide documentation or evidence of implementation of its corrective actions as they are still ongoing.

The responses also included a revised procedural document titled “Adverse Event Reporting – United State”, DP-20087, Revision 101, which incorporate a process to identify precedent events. However, after reviewing the document, the following deficiencies were noted:

A. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2).
  a. There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event.
  b. Although the procedure includes instructions for how your firm will evaluate information about an event to make a reportability decision, it fails to include instructions for making determinations in a timely manner.

B. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically:
  a. Instructions for how to complete the FDA 3500A form.
  b. A process for submitting MDRs electronically in accordance with 21 CFR 803.20(a)(3).
  c. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within your firm.

C. The procedure does not describe how your firm will address documentation and recordkeeping requirements, as required by 21 CFR 803.17(b), including:
  a. Documentation of adverse event related information maintained as MDR event files.
  b. Information that was evaluated to determine if an event was reportable.
  c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, as required under 21 CFR 803.18(b)(1)(i).

Furthermore, your firm did not provide documentation or evidence that the corrections and corrective actions, including a retrospective review of precedent events and submission of two referenced malfunction MDRs, have been implemented and completed.

2. Failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Act caused by the device which may present a risk to health, as required by 21 CFR Part 806.10. For example, your firm issued a Customer Information Bulletin dated on December 3, 2015, offering a replacement of the supercapacitor (contained on the main boards) for the Medfusion 3500 and 4000 Infusion Pumps, due to the early failure of the supercapacitor after a supplier change in 2013. This failure led to a “Backup Audible Alarm error” or “Supercap POST (power on self-test) error” which requires that a biomed code be entered before the pump can be returned to use and causes a potential delay of therapy. Your firm did not submit a written report to FDA of the removal, as required by 21 CFR 806.10.

As of October 1, 2021, there is no record of Smith Medical ASD, Inc. submitting a Report of Correction or Removal to FDA.

This inspection also 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, including software validation and risk analysis and the results shall be documented in the DHF as required by 21 CFR 820.30(g). Specifically,

A. You have not validated the Medfusion® software version 1.6.1 for use with the firmware bootloader version 1.2; your firm estimated that (b)(4) units potentially exist in the field with an unvalidated software combination. Your software and firmware are routinely changed in production, yet your firm did not define a design input for downgrading the revision of firmware to match the revision of software on the pump.
B. Your design change CO-10073172 released a “pre-release” of software version 1.7.0 and base bootloader 1.2 for the Medfusion® 4000 that was not validated. You did not have documentation showing these base boards (also known as interconnect boards) were appropriately updated to a final validated version of software prior to release and shipment to customers.
C. Your design change to the power cord retainer for the Medfusion® 4000, did not have an adequate validation or rationale why no formal validation was required for fluid ingress. An evaluation was completed; however, the evaluation did not define any acceptance criteria, nor did it specify key parameters identified in the previous 2013-2014 investigation RTR-007, Revision 100; and ETR-228, Revision 100, such as the salinity of the solution, whether the outlets were grounded and whether the flow rates used in 2019 were comparable to the previous investigations.

2. Failure to establish procedures for corrective and preventative action, with documentation of activities and results as required by 21 CFR 820.100. Specifically, your CAPA procedure, Corrective and Preventive Action (CAPA), SOP-20046 has not been adequately established.
A. Your CAPAs did not implement changes in methods or procedures to correct or prevent the identified quality problems, for example:
  i. CAPA-000722, opened on October 21, 2020, found design changes to make the pressure doors wider lowered the flow rates and did not guarantee the claimed flow rates in the IFU can always be met. Your firm has received three complaints alleging deaths and seven complaints for serious injury due to this design change since the beginning of 2019. The CAPA was still in investigation phase, with a due date of May 14, 2021.
  ii. CAPA 19MBIS069 was opened on April 11, 2019 to address complaint CC-0031585 for an over-infusion event on the Medfusion® 3500 with software version 4.1.5. The CAPA investigation found the software error was also present in software version 5.0.0 and 6.0.0. While Software version 6.0.0 was fixed, it appears no action was taken for Software version 5.0.0.
  iii. CAPA 18MOAK003 was opened on July 28, 2017 for out-of-box issues regarding failing the Force Sensor Test. The design controls corrective actions in this CAPA were then transferred to CAPA 19MOAK090, opened on June 20, 2019. During the implementation results phase, the Design Controls corrective action was stated to take place in a separate supplier change document, under Design Change Assessment (DCA) B10004228, Revision 100, Requested on July 23, 2019. These supplier and design changes were still open as of March 30, 2021. The DPRA found 121 complaints for this failure mode from May 01, 2016 – February 28, 2018.
B. CAPAs have not adequately verified or validated the corrective actions to ensure the changes were effective and do not adversely affect the finished device.
  i. CAPA 18MOAK030 was opened on October 30, 2017 for Medfusion® pumps that are not recognizing the correct syringe size. The CAPA added a receiving inspection step for the barrel clamp guide and spring, clarified the barrel rod drawing, and added the broken edge dimension for the barrel rod. However, the CAPA did not include a revalidation of the sub-assembly or full assembly, nor are there test results showing these changes were effective and did not adversely affect the product. The verification of effectiveness section of the CAPA only verifies that there were no complaints for the spring slipping over the barrel rod, 6 months after implementation for these changes. CAPA 18MOAK030 resulted in a recall, reported on November 27, 2017 and expanded on April 03, 2018. At least 35 complaints have been received for this failure mode since January 1, 2019.
  ii. CAPA-000580 / 20CAPA009 does not have a verification of effectiveness. The implementation phase states that all actions will be addressed by the Quality Plan #B10005892. There was no approved procedure in place to ensure a verification of effectiveness in Quality Plans and your management stated there was no verification of effectiveness for these corrective actions. Three other CAPAs and one CAPA request were also closed to this Quality Plan: 19MMSP067, 19MMSP058, 19MMSP050 and 20CAPA064.
C. Quality data sources are not being analyzed.
Your firm’s procedure “Complaints Signals Review Process,” DP-20099, Revision 100 is your only procedure for quality data analysis. This procedure does not address the review of other sources of quality data, such as Application Support.
D. Your procedure, “Nonconforming Event (NCE),” SOP-20048, Revision 102 has not been adequately implemented.
NCR-000111 was opened on 25-Aug-2020 for an increased number of field complaints and sales team reports from customers experiencing issues with the Level 1 Trauma Tower flow rates and fluid being left in 300 ml blood bags. The risk analysis was marked as “negligible,” despite this failure mode being linked with at least three deaths.

3. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as per 21 CFR 820.198(a). Specifically,
A. Your firm does not maintain records of investigations for complaints that come through application support. Section 6.1.1 of your procedure, Product Complaint Investigation, DVDP5514, Revision 100, requires all product complaint investigations to be documented within Investigation Objects in the complaints management system. However, all complaints originating from your application support helpline only have complaint investigations documented in associated e-mail records, and this does not represent any complaints that are received over the phone.
B. Your procedure, Product Complaint handling, SOP 200077, Revision 100, states the complaint handler will update the Post Investigation Hazard Code after the investigation has been completed. Three of 15 complaints (CC-0044272, CC-0041616 and CC-0043719) reviewed had "N/A - No Fault Found" as the "Post Investigation Hazard Code" when the returned product was determined to have a known problem with the barrel clamp guide assembly.

4. Failure to establish and maintain a Design history file for each type of device to demonstrate the design was developed in accordance with the approved design plan and the requirements of 21 CFR 820, as required by 21 CFR 820.30(j). Specifically, your firm’s procedure, Global Post-Market Regulatory Change Impact Assessments, DVDP2500, Revision 100 requires a Letter to File for a change to a Class II U.S. product that is deemed “nonsignificant”. Review of your Design History File for the Medfusion® 4000, found at least 5 Letters to File have not been retained.

We acknowledge your firms’ responses that indicate you have implemented corrective actions; not all your corrective actions have been completed. The effectiveness of the corrections you have taken will be evaluated during your next inspection.

Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.

In addition, we understand you have recently reached out to the Center for Devices and Radiological Health (CDRH) regarding the technological characteristics and intended use of your Medfusion® model 4000 Syringe Infusion Pump device (K111386) cleared on August 29, 2011, which is currently in commercial distribution. CDRH will use the information you have submitted to determine the appropriate regulatory pathway for this device.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

If you have questions regarding any issues in this letter, please contact Compliance Officer, Demetria Lueneburg at 615-758-7210 or at Demetria.Lueneburg@fda.hhs.gov. Please send your reply electronically to Melissa Michurski, Director of Compliance Branch, at ORADevices2FirmResponse@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.

Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health
Division 2 Central

Courtney H. Lias, Ph.D.
OHT3: Office of GastroRenal, ObGyn,
   General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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