MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAXPRISMAX SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	955626
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The prismax machines experienced multiple issues, including various alarms, filter set failures, and thermax "failure to inflate" errors.Despite attempts to prime the machines, the process could not be completed due to air in the line, even though no air was actually present.These problems resulted in a delay of care by 2-3 hours.

• Brand Name: PRISMAXPRISMAX SYSTEM
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 22929755
• Report Number: 22929755
• Device Sequence Number: 10294430
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/21/2025
• Report Date (Section F): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 955626
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Date Report Sent to FDA: 08/21/2025