MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 300; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 300

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  malfunction  

Event Description

Dialyzer failed; dialog alarmed for blood leak after 2 min of tx.Dialysate effluent line rose tinged.Pt disconnected without returned blood.Pt started on new machine.Dialyzers keep the blood and dialysate separate so that the blood can be safely cleaned, when a dialyzer leaks blood it allows patients blood to go down the drain and has potential for contaminants to get to the patients blood.

• Brand Name: REVACLEAR 300
• 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: 11640670
• MDR Text Key: 244619291
• Report Number: 11640670
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 300
• Device Lot Number: C620312602
• 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: 03/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1