The FDA has issued an early alert regarding a critical issue with certain Vantive Prismaflex dialysis tubing sets. Clinical, quality, and regulatory professionals should be aware of updated use instructions for affected devices, which are employed in continuous renal replacement therapy and related procedures. This alert highlights potential risks to patient safety and treatment efficacy.
What Changed?
On January 6, Vantive informed affected customers of a potential issue where Prismaflex set deaeration chambers may become dislodged from Prismaflex Control Units. This dislodgement can trigger an “Air in Blood” alarm during the priming phase or during therapy, resulting in therapy delays, interruptions, or blood loss due to clotting.
Importantly, this issue does not impact PrisMax Control Units, which have a different deaeration chamber holder design. To date, no serious injuries or deaths have been reported as of December 17, according to Vantive and FDA communications.
Who Is Affected?
The affected devices include Vantive Prismaflex sets used with Prismaflex Control Units. These devices are designed to assist in continuous fluid management, renal replacement therapies, blood purification, and plasma exchange. Health care professionals using the affected devices should take immediate precautions.
How to Mitigate Risks
Vantive’s communication outlines actions users should follow to reduce potential risks associated with the affected tubing sets:
- During therapy, monitor the deaeration chamber to ensure it remains in an upright position within the holder.
- Check that there are no kinks in the tubing and that the deaeration chamber remains visible.
- If the “Air in Blood” alarm activates, verify if air is present. If no air is detected, inspect for deaeration chamber dislodgement or clots.
- For dislodgement with clotting, stop therapy and replace the tubing set per the Prismaflex operator’s manual.
- For dislodgement without clotting or air, secure the chamber upright and continue as directed by the operator’s manual.
Those who purchased the product through distributors should follow their distributor or wholesaler’s specific instructions.
Understanding the Importance of Unique Device Identifiers (UDI)
The Unique Device Identifier (UDI) system is essential for identifying medical devices throughout their distribution and use. This allows for detailed reporting and analysis of adverse events, helping health care providers and regulators address issues more efficiently. To identify a UDI on a label or gather more details, users can access the AccessGUDID database.
How to Report Adverse Events
Health care professionals and consumers who encounter adverse reactions or quality issues with these devices should report their experiences to the FDA’s MedWatch program via the FDA Safety Information and Adverse Event Reporting Program. This ensures prompt investigation and resolution of reported issues.
Conclusion
The FDA is closely monitoring this high-risk device issue and will continue to provide updates. Providers using affected Prismaflex dialysis tubing sets must follow Vantive recommendations to maintain patient safety and treatment efficacy. For additional guidance, refer to the Prismaflex Control Unit operator’s manual and check for updates on the FDA’s webpage.
Disclaimer
This article provides general information intended for clinical, quality, and regulatory professionals. It is not legal or medical advice. For official guidance, consult the FDA’s full announcement and your institutional policies.