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

Catalog Number 114748

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a particulate matter was observed inside the blood header connector of one unit of revaclear 300 apac during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11240944
• MDR Text Key: 234969921
• Report Number: 9611369-2021-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114947
• UDI-Public: (01)07332414114947
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 114748
• Device Lot Number: 0-9626-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1