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 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

(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 cap of a revaclear 300.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6 and h10 h10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the two provided photos showed a wet product out of the original packaging.Photo one showed the product label and photo two revealed the header area had a black particle.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: 10986164
• MDR Text Key: 220970547
• Report Number: 9611369-2020-00183
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114947
• UDI-Public: (01)07332414114947
• 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: 01/19/2021

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: 04/30/2023
• Device Catalogue Number: 114748
• Device Lot Number: 0-9621-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1