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

Catalog Number 114745L

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

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number:  (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that upon opening the packaging of a revaclear 300, two dark spots were observed inside the fibers.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual sample was not received for evaluation, however, a picture was provided.Visual inspection observed an image of the header cap area of a dialyzer.On the top of the fiber bundle, were two small dark 'spots', that appeared to be possible singe or burn marks.While the spots looked to be fixed to the bundle top, the actual sample would have to be analyzed for confirmation.The discoloration may be consistent with singe or burn marks caused by debris on the hot blades, the manufacturing equipment used to cut the fiber bundle.Fixed particulate matter, that is not loose in the header cap area, may have potential to enter the dialysate path, however would not be probable to enter the blood path.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 300
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11331423
• MDR Text Key: 241931255
• Report Number: 3006552611-2021-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123055
• UDI-Public: (01)07332414123055
• 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: 03/18/2021

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 Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Catalogue Number: 114745L
• Device Lot Number: C620310902
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1