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

Model Number	955626
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Pt was ordered for cvvh [continuous veno-venous hemofiltration] on [date redacted] due to soft bps [blood pressure] and concerning infection to hd [hemodialysis] site.Machine set-up and priming, which takes nearly an hour, resulted with error messaging reading, b2084, "a system failure has occurred.Warning: discontinue treatment." the next machine was attempted for use which took another hour to set up in pt's room.The next machine also gave error messages creating a further delay and need for gathering more supplies and a change of machinery once again.The patient's cvvh was delayed multiple hours due to faulty machines.

• 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: 22728230
• Report Number: 22728230
• Device Sequence Number: 8989714
• 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): 07/28/2025
• Report Date (Section F): 07/28/2025

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: Health Professional
• 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
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Date Report Sent to FDA: 07/28/2025