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

Catalog Number 114749M

Device Problems Component Missing (2306); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that particulate matter was observed within a revaclear 400.It was also reported that "the amount of fiber in the dialyzer is too loosely spread out, seems to be missing a section of the fiber".This was observed during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.During visual inspection, the header cap was removed, and the fibers were noted to be burned.No particulate matter was identified.The reported condition of particulate was not verified; however, the burnt fibers was verified.The cause of the condition of the burnt fibers could not be determined; however, the most probable cause was due to an issue during manufacturing.During the production process hot blades and thermoforming can result in burned fibers.If there is improper or incomplete thermoforming of the fiber bundle can result in a bad cut at hot blade, leading to burned fibers.Production process controls to prevent and detect such defects include 100% visual inspection before a header cap is added to the device.There is another visual inspection when a header cap has been added to the device.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
• 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: 17943908
• MDR Text Key: 325768896
• Report Number: 3006552611-2023-00052
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414126186
• UDI-Public: (01)07332414126186
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114749M
• Device Lot Number: C422226901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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: N/A.