Dive Brief:
- The Food and Drug Administration sent a warning letter in early April to ICU Medical, alleging the company failed to submit premarket notifications for changes to infusion pumps.
- FDA inspectors found ICU Medical made multiple changes to the Medfusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump that could significantly affect the devices’ safety or effectiveness.
- The warning letter follows a series of recalls and quality issues at ICU Medical since the company acquired Smiths Medical from London-based conglomerate Smiths Group in 2022.
Dive Insight:
The FDA inspected ICU Medical last summer, and the inspectors found the company had made changes to its Medfusion and CADD infusion pumps to address issues identified via adverse event reports.
“Such modifications can significantly impact the functionality of the device with respect to the infusion pumps delivery profile, alarm functionality, etc., and affect the device’s risk profile for risks related to under- or over-infusion, delay in therapy, incomplete therapy or false alarms leading to adverse health effects for patients such as overdose, volume overload or cardiorespiratory compromise,” the FDA said.
ICU Medical made changes to fix problems identified in a Class I recall. The company recalled the devices over problems with the delivery of fluids, false alarms and therapy interruption, according to the letter, but failed to seek 510(k) clearance for the fixes. Labeling that the device software has not undergone FDA review is not sufficient, the agency said.
ICU Medical’s regulatory change impact assessment for a 2023 Medfusion software update identified new risks or significantly modified risks. ICU Medical’s own procedure indicates a 510(k) filing is needed when such risks are identified, the FDA said, but the company did not make a submission.
The warning letter is the latest in a series of regulatory actions against companies that allegedly failed to notify the FDA of changes to their medical devices. Abbott received a warning letter in November 2022 after the FDA found the company “made multiple significant design changes” to a heart disease test without submitting new premarket notifications.
Earlier this year, the FDA sent a warning letter after finding Q’Apel Medical’s aspiration catheter had a tip that was not described in the company's regulatory submission. Last year, the agency accused Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances.
