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

Catalog Number 114749

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  malfunction  

Event Description

It was reported that during priming with a revaclear 400, an external fluid leak was observed due to a damaged port.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not received for evaluation however photos were provided.The visual inspection of the provided photos shows the product wet and one piece from the hansen connector was missing.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 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12501467
• MDR Text Key: 282296406
• Report Number: 9611369-2021-00240
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414114954
• UDI-Public: (01)07332414114954
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 114749
• Device Lot Number: 1-9710-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.