Smiths Medical warned by FDA for multiple violations

Regulatory NewsRegulatory News | 24 November 2021 |  By 

The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.
The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s NORMOFLO fluid warmers due to the possibility of harmful levels of aluminum leaching into the fluid path of the warmers. The Class I recall affected over 500,000 fluid warmers.
Lax MDR procedures 
According to FDA, the company had received complaints that “reasonably” suggested that its Medfusion Syringe Pump malfunctioned after an unexpected battery depletion while in use, which could potentially cause a death or serious injury if the malfunction were to recur.
Yet the firms’ MDR procedures were reviewed and found to be inadequate, since the adverse event reporting procedure “does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting,” said the warning letter. It added that “there are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event.”  For example, the company had no instructions for staff on how to complete the FDA 3500 form.
Faulty CAPAs
The firm was cited for failing to establish and document CAPA procedures as required under 21 CFR 820.100 for its infusion pumps.
“Your CAPAs did not implement changes in methods or procedures to correct or prevent the identified quality problems,” said FDA. For example, a CAPA was opened on 21 October 2020 which found that design changes to make the pressure doors wider to lower flow rates did not guarantee that claimed flow rates in the instructions for use could be met. The firm subsequently 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.”
Smiths also did not adequately investigate “nonconforming” events. The company opened an investigation on 25 August 2020 to follow up on 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.”
Inadequate Validation
The firm also failed to establish and maintain validation procedures to ensure that devices conformed to defined user needs for its infusion pumps.
For example, a design change to the power cord retainer “did not have an adequate validation or rationale why no formal validation was required for fluid ingress.”
Faulty complaint handling
The company was also lambasted for failing to establish procedures for receiving and evaluating complaints. For example, while all complaints were documented in email records, those received over the phone were not documented. Also, three complaints reviewed had a “no fault found” when returned products had a known problem with the barrel clamp guide.
The firm was given 15 days to respond to the warning letter.
Warning letter


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