MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	114746
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during set-up with a revaclear 400 set, ¿some stains¿ were observed inside the fibers of the dialyzer.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection with the naked eye found that the product was wet.Two brownish particles were found in the header and luer area of the product.The reported condition was verified.An infrared analysis of the particles was performed.A spectrum could be recorded; however, a suitable comparison spectrum could not be found, therefore a definite statement could not be made about the material.The cause of the condition could not be determined.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 400
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8176134
• Report Number: 9611369-2018-00147
• Device Sequence Number: 1279491
• Product Code: KDI
• UDI-Device Identifier: 07332414114923
• UDI-Public: (01)07332414114923
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K130039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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: 07/31/2021
• Device Catalogue Number: 114746
• Device Lot Number: 8-7038-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1