PrisMax System software anomaly affects therapy parameter settings
The PrisMax System has a software defect that can silently revert custom therapy parameters to defaults when using the Same Patient function without notifying the operator.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a software defect creating risk of improper therapy parameters. No injuries, hospitalizations, or illnesses reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
The PrisMax System, a renal replacement therapy device manufactured by Baxter Healthcare Corporation, is subject to a worldwide recall affecting 3,513 units due to software anomalies in its parameter-management function.
The defect occurs when an operator uses the "Same Patient" function after entering non-default values for either the Patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL). The system silently reverts these parameters to their default values without alerting the operator. The display will show the original values once treatment restarts, but this absence of notification means the operator may not realize the settings have changed.
This defect creates a risk that patients may receive therapy with unintended parameter settings, potentially affecting treatment adequacy. The affected units were distributed worldwide, including the United States, Canada, Mexico, Brazil, and numerous European, Asian, and Pacific countries.
Healthcare facilities and operators using the PrisMax System should review their device settings carefully and verify whether this anomaly may have affected patient care.
The recalled product
- Product
- PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- software-defect
- parameter-reversion
- interface-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- a) 955558
- UDI 07332414124359
- b) 955627
- UDI 07332414124700
- c) 955701
- UDI 07332414125844
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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