MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX ACCESSORY, AUTO EFFLUENT; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	115370
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was receiving continuous renal replacement therapy with baxter healthcare prismax machine.The rn noticed effluent leaking from the small 1-liter bag of the auto effluent accessory kit.Immediately, the rn stopped therapy and replaced the crrt tubing (prismaflex extra corporeal circuit with filter, thermax blood warmer and auto effluent accessory kit.The replacement process delays therapy for at least 20 minutes.The fluid was leaking from the junction of tubing and bag (pictures available).The baxter rep will be removing all auto effluent accessory products with lot # 22h2901 and replacing with new products.

• Brand Name: PRISMAX ACCESSORY, AUTO EFFLUENT
• 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: 16501519
• Report Number: 16501519
• Device Sequence Number: 20393369
• Product Code: KDI
• UDI-Device Identifier: 07332414118914
• UDI-Public: (01)07332414118914
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2023
• Report Date (Section F): 02/28/2023

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
• Device Model Number: 115370
• Device Catalogue Number: 115370
• Device Lot Number: 22H2901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2023
• 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 Sex: Male
• Date Report Sent to FDA: 02/28/2023