The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Affected Product
The FDA is aware that Vantive has issued a letter informing affected customers that Prismaflex Control Units have updated use instructions.
Affected devices:
| Device Name | Product Code | UDI-DI | Lot Numbers |
|---|---|---|---|
| PRISMAFLEX ST100 SET US | 107636US | 00085412954073 | All lots including and manufactured after 24G0072 |
| PRISMAFLEX ST150 SET US | 107640US | 00085412917696 | All lots including and manufactured after 24F0085 |
| OXIRIS SET | 112016 | 07332414102234 | All lots including and manufactured after 24G0041Z |
| PRIMSAFLEX M100 SET | 106697 | 07332414064556 | All lots including and manufactured after 24F0077CA |
| PRISMAFLEX M150 SET | 109990 | 07332414090005 | All lots including and manufactured after 24F0100CA |
| PRISMAFLEX HF1000 SET | 107140 | 07332414069254 | All lots including and manufactured after 24G0034CA |
| PRISMAFLEX HF1400 SET | 107142 | 07332414069315 | All lots including and manufactured after 24F0094CA |
| PRISMAFLEX TPE2000 SET | 114093 | 07332414111038 | All lots including and manufactured after 24J0106 |
What to Do
When using affected products, monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder.
On January 6, Vantive sent all affected customers a letter recommending the following actions:
- You may continue to perform therapy using affected Prismaflex sets. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder.
- Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright position, please consider the following:
- Ensure there are no kinks in the tubing and that the deaeration chamber remains visible.
- If the Prismaflex Control Unit issues an “Air in Blood” alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present.
- If no dislodgement, please follow the operator’s manual instructions for “Air in Blood” alarm.
- In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator’s manual to stop the therapy and replace the set.
- Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator’s manual to proceed with treatment.
- If you purchased this product from a distributor, please note that responding using the Vantive Customer Reply Form is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions.
- If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Reason for Alert
Vantive stated that Prismaflex Set deaeration chambers may dislodge from the Prismaflex Control Unit, as shown above. This issue does not affect PrisMax Control Units, as these devices have a different deaeration chamber holder design.
A dislodged deaeration chamber may lead to an “Air in Blood” alarm on the Prismaflex Control Unit. The alarm may occur during the priming phase prior to initiating therapy, or during therapy. This may result in delays or interruptions to therapy and blood loss due to clotting and failure to return blood manually.
As of December 17, Vantive has not reported any serious injuries or deaths associated with this issue.
Device Use
Different Prismaflex sets are used with PrismaFlex control units or PrisMax control units in providing continuous fluid management and renal replacement therapies, blood purification, or therapeutic plasma exchange.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Vantive at 833-542-2778.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
