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

Catalog Number	110634
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A nurse reported particulate matter inside a revaclear max dialyzer.The customer reported that the particle was found on the inside of the top end of the dialyzer.This was noticed before use on patient.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection revealed particulate matter under the header of the device.The particle was found to be adhered to the header/housing material.Microscopic inspection of the particle revealed a mass of brown fibers approximately 2.0mm in length.Fourier transform infrared spectroscopy (ftir) revealed that the particulate matter was consistent with cellulosic material.Polarized light microscopy was used to inspect the brown fibers.The fibers exhibited poor extinction in limited portions and no extinction in the remainder of the fiber.This is consistent with paper fibers.The particulate matter was identified to be a mass of paper fibers, possibly from a cardboard source.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A nonconformance has been opened to address this issue.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 MAX
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - OPELIKA; opelika AL
• MDR Report Key: 7355457
• Report Number: 3006552611-2018-00002
• Device Sequence Number: 10907884
• Product Code: KDI
• UDI-Device Identifier: 07332414101701
• UDI-Public: (01)07332414101701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 10/20/2019
• Device Catalogue Number: 110634
• Device Lot Number: C417227701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.