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

Catalog Number 114746L

Device Problem Leak/Splash (1354)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported that during use, two (2) units of revaclear 400 had an external blood leak.Blood was not returned to the patient both times.There was no report of patient injury or medical intervention associated with this event.

Manufacturer Narrative

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

Manufacturer Narrative

The actual sample was received for evaluation.No external blood leak was verified, however, the dialyzers were found to have polyurethane (pur) exceeding the support ring of the dialyzer, which has a yellow discoloration on the dialyzers.Once blood is put into the dialyzer, the yellow discoloration turns to a bright red color.The most likely cause of the red and yellow discoloration of the fibers is from polyurethane (pur) used during the manufacturing of the dialyzer due to the improper distribution pur on the fibers.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
• Manufacturer (Section G): BAXTER HEALTHCARE - OPELIKA; 1101 jeter ave; opelika AL 36801
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15798702
• MDR Text Key: 307185063
• Report Number: 3006552611-2022-00027
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124076
• UDI-Public: (01)07332414124076
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114746L
• Device Lot Number: C422202301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.