PrisMax System, Product Code 955724
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is issuing a correction for its PrisMax System (Product Code 955724) due to software issues affecting treatment parameters. When operators enter custom values for the patient Gain/Loss Limit or Return Pressure Drop Limit (RDL) and then use the Same Patient function, the system reverts these values back to defaults without alerting the user. The system's interface will display the original values when treatment restarts, but users will not receive a warning that the settings have changed. The RDL value resets immediately upon selecting Same Patient, while the Gain/Loss Limit resets when patient weight or hematocrit is changed during treatment.
The PrisMax System has been distributed worldwide across 296 units in numerous countries including the United States, Canada, Mexico, Brazil, and throughout Europe, Asia-Pacific, and the Middle East. All serial numbers of the affected product are included in this correction.
The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment.
Reason for recall: This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment. Distribution: Worldwide distribution - US Nationwide and the countries of Mexico, Brazil, Jamaica, Trinidad and Tobago, Canada, Australia, Singapore, Hong Kong, Vietnam, New Zealand, Korea, Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom. Quantity: 296 units Lot/code info: GTIN 07332414126018, All Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.