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

Catalog Number	114746L
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
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 black particulate was observed in the header of a revaclear 400.The event occurred prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, photographs of the sample were provided for evaluation.During visual inspection of the provided photographic samples, two black spots were observed at the hot blade of the pur block from the header cap of the dialyzer.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause of the burned fiber is related to the production process.If there is improper or incomplete thermoforming of the fiber bundle, this can result in a bad cut at hot blade, leading to burned fibers.Production process controls are in place to prevent and detect such defects which include 100% visual inspection.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
• Common Device Name: 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: 16577081
• Report Number: 3006552611-2023-00008
• Device Sequence Number: 14623065
• Product Code: KDI
• UDI-Device Identifier: 07332414124076
• UDI-Public: (01)07332414124076
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: Other
• Device Expiration Date: 08/12/2025
• Device Catalogue Number: 114746L
• Device Lot Number: C422221501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2022
• 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: Unknown