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	02/09/2018
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 an unknown black dot on the tip of the revaclear dialyzer strands.The customer stated that the particle was found on the inside of the top end of the dialyzer.This was noted during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection revealed particulate matter under the header.Microscopic examination revealed a 0.6mm deposit of fine black particles less than 0.1mm in size.The particles were analyzed using energy dispersive x-ray spectroscopy (edxs).The composition of the particles was not clearly identified but was suggestive of a carbonaceous material such as toner or ink.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: 7355498
• Report Number: 3006552611-2018-00003
• Device Sequence Number: 1172779
• 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: 10/25/2019
• Device Catalogue Number: 110634
• Device Lot Number: C417228201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: 02/23/2018
• 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