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

Model Number A6003

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

Leak from effluent set.Effluent accessory used with prismax cwh device.Cc biomed repeated the event and showed the fluid leaked from the connection to the smaller of the two bags with the kit.Staff reported that two additional event with leaks from effluent accessory bags used in the icu.

• Brand Name: PRIMAX AUTO EFFLUENT ACCESSORY
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEAL DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 1 baxter pkwy; deerfield IL 60015
• MDR Report Key: 14514006
• MDR Text Key: 292975892
• Report Number: MW5109926
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A6003
• Device Lot Number: 212901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1