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

Model Number 115370

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2022

Event Type  malfunction  

Event Description

The patient was receiving crrt with the baxter prismax machine.The rn set up the machine with a prismaflex extra corporeal circuit with filter, thermax blood warmer, and auto effluent drain accessory.When set -up was complete, the rn started therapy per the machine's instructions.Soon after starting the therapy, the rn received the following low priority alarm " fluid in drip tray".The alarm is triggered by drip tray sensors detecting fluid.The rn was directed to check for any disconnections, punctures, or leaks.The rn noticed a leak in the small effluent bag (1 liter) on the lower portion of bag where tubing enters the bag.The rn was going to remove the auto effluent drain and set-up another type of effluent bag.The machine wanted the rn to change the entire circuit.The baxter individual told the rn to patch up the hole in the bag as best as possible or just change the entire circuit again.When the rn was explaining the situation to 1-800 person and the rn felt the baxter person conveyed this issue had been ongoing.The entire prismax circuit was changed.

• Brand Name: PRISMAX ACCESSORY, AUTO EFFLUENT
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15671489
• MDR Text Key: 302401197
• Report Number: 15671489
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/18/2022,10/14/2022

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 Lot Number: 22F1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1