Baxter (NYSE:BAX) issued a device correction in Europe for its PrisMax hemodialysis machine due to a software anomaly.
The correction relates to a software anomaly occurring during use. If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the “Same Patient” button, the PrisMax system may display values from the original prescription profile instead of the current one, according to a safety notice out of Germany.
The system’s interface is supposed to always ask the user to confirm all prescription values before initiating therapy or when modifying during therapy. Baxter said the anomaly only occurs if a saved prescription file is used when setting up treatment.
Should such changes occur in prescription settings without direct manipulation by the operator, it could result in treatment interruption, hyper/hypovolemia, hyper/hypocalcemia, or inadequate solute removal depending on which parameters have changed. To date, there have been no reports of serious injury related to this issue, the notice said.
Users can continue to safely use the PrisMax system with software version 2.x until the system receives an upgrade to version 3.x. To ensure patient safety, operators must follow the system’s manual and confirm that all prescription fields are accurate before starting a treatment or making changes during therapy. Baxter said only trained operators should use the device.