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 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that before use with a revaclear 300 apac set, particulate matter inside the dialysate port was observed.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device and photographs of the sample were received for evaluation.Visual inspection of the provided photos shows the product connected to the blood line and filled with liquid solution.In the header a black particulate matter was visible.Visual inspection with the naked eye of the sample showed the product wet without packaging.A brownish particulate matter stocks on the pur (polyurethane) potting surface and at the o-ring sealing.A material analysis was not performed because the particulate matter cannot be detached from the surfaces and is too small to perform an analysis.The reported condition was verified.The cause of the condition 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: 10871407
• MDR Text Key: 218587885
• Report Number: 9611369-2020-00168
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 114748
• Device Lot Number: 0-9623-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1