Prismax and Thermax Systems

Issue

Vantive is issuing an urgent medical device correction due to the following three issues: Prismax system alarm T2309: air detected in prime may be raised after priming with a low liquid level in the deaeration chamber. The system correctly detects the presence of air within the disposable set and raises the alarm at the end of priming if the condition is present. Users should follow the on-screen instructions to reprime the disposable set. Prismax system alarm T0830: blood leak detected may be raised when no blood leak is present, or the operator may have difficulty normalizing the blood leak detector (BLD) leading to Prismax system alarms T1313: BLD normalize failed, T0853: normalization failed, or T1205: BLD self-test failure. Operators should follow the on-screen instructions and return the blood in the disposable set if connected to a patient. Thermax system may be unable to detect the presence of a bag on the Thermax blood warmer unit leading to difficulty setting up therapy, or Prismax system alarm T2284: Thermax disposable not inserted. Operators should follow the on-screen instructions and return the blood in the disposable set if connected to a patient. Recall start date: July 28, 2025