MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DIALYZERS / ULTRAFILTERS (REVACLEAR); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE

Catalog Number	114746L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported two (2) revaclear 400 experienced an internal blood leak.During hemodialysis therapy the extracorporeal system was observed full, and the capillary membrane ruptured.Therapy was suspended and the complete system was changed.Therapy was restarted and the event reoccurred.Therapy was discontinued and the set was discarded.The patient lost a total of 400ml of blood.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information added to h3, h6 and h10 h10: the actual device was not available; however, photographs of the sample were provided for evaluation.During visual inspection of the provided photographic samples, the photos show both ends of a dialyzer with a red discoloration at the ends of the fiber bundle.This red discoloration is not an internal blood leak inside the dialysate path, instead, the red discoloration is an incorrect distribution of pur (polyurethane) being coated on the outside of the fibers.The reported condition of a blood was not verified.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: DIALYZERS / ULTRAFILTERS (REVACLEAR)
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE
• 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: 16708959
• Report Number: 3006552611-2023-00011
• Device Sequence Number: 6080388
• Product Code: KDI
• UDI-Device Identifier: 07332414124076
• UDI-Public: (01)07332414124076
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K130039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/16/2025
• Device Catalogue Number: 114746L
• Device Lot Number: C422225001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 83 KG