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

Model Number	A6003
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was receiving crrt, and the rn noticed effluent dripping from the 1-liter and 5-liter bags.The auto-effluent drain accessory continuously pumps effluent collected during therapy into a drain, while providing the accuracy of a scale-based measurement system.Eliminating effluent bag changes minimizes user exposure to effluent.The loss of effluent can affect the patient's therapy and increase exposure of healthcare worker to effluent.The rn had to completely remove the current crrt set prismaflex extra corporeal circuit with filter, thermax blood warmer, and auto effluent drain accessory.The machine would not allow the rn to only replace the auto effluent drain accessory.Changing of the tubing causes a delay in therapy for at least 20 minutes.Also, the cost increases because the critical care unit has to utilize another set early.The baxter rep told the leadership to remove all sets with the lot # 22h2901.The rep will take the tubing with lot # 22h2901 and replace with a new lot #.

• 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: 16501478
• Report Number: 16501478
• Device Sequence Number: 3290597
• 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): 02/28/2023
• 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: A6003
• 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: Female
• Date Report Sent to FDA: 02/28/2023