MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114746L

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

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a brown stain was observed inside a revaclear 400 when the product was taken out of its packaging.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to h10.H10: the actual device was not available; however, four photographs of the sample was provided for evaluation.The pictures showed the device label as well as the 'brown stain' particulate matter reported.The discolored area was visible in the header cap area of the dialyzer.The reported condition was verified.The cause could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: REVACLEAR 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11035712
• MDR Text Key: 222299855
• Report Number: 3006552611-2020-00009
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124076
• UDI-Public: (01)07332414124076(10)
• Combination Product (y/n): Y
• PMA/PMN Number: K130039
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2023
• Device Catalogue Number: 114746L
• Device Lot Number: C620408804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1