Recall Z-0992-2022 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
PrisMax System, Product Code 955724
| Date | Mar 15, 2022 |
| Status | Open, Classified |
| Reason | 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 ret |
| Root cause | Under Investigation by firm |
| Action | The firm notified its consignees be letter on 03/15/2022. The following instructions were provided: "1. Operators may continue to safely use the PrisMax System. To ensure patient safety, there are two approaches to address the anomalies: Approach 1: Choose new patient at every filter set change. This will require re-input of all prescription settings and therapy will begin without prescription settings and treatment data from the previous filter set. Approach 2: Choose Same Patient when changing a filter set. Check and correct the Gain/Loss Limit or RDL prior to starting treatment. See Att |
| Quantity | 296 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.