Devices

Alert Issued on Vantive’s Prismaflex Systems

FDA is alerting healthcare providers to a potentially high-risk issue involving dialysis tubing sets used with Prismaflex systems after manufacturer Vantive warned that a key component may become dislodged during treatment. In an agency early alert, Vantive is said to have notified customers that updated use instructions are needed for certain Prismaflex sets because the deaeration chamber can dislodge from the Prismaflex Control Unit during priming or active therapy.

According to the agency, the issue affects multiple Prismaflex tubing sets across all lots manufactured after specific dates, including ST100, ST150, M100, M150, HF1000, HF1400, TPE2000, and Oxiris sets. The problem does not affect PrisMax Control Units, which use a different deaeration chamber holder design.

Vantive said a dislodged deaeration chamber can trigger an “Air in Blood” alarm on the Prismaflex Control Unit, potentially leading to therapy delays or interruptions. In some cases, the company said, blood loss may occur due to clotting and the inability to return blood manually if therapy must be stopped.

Prismaflex systems are used in hospitals and critical care settings to provide continuous renal replacement therapy, blood purification, fluid management, and therapeutic plasma exchange. FDA advised healthcare facilities using the affected products to review the manufacturer’s instructions carefully and to monitor patients closely during treatment.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome