MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2251 2K 2.5CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-2251-0
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (biomed) reported via email that the final conductivity was 0.4 to 0.5 less than tcd which put conductivity at a lower limit or below.The biomed reported that multiple machines were checked with a known good concentrate, same product but different lot number, and the conductivity was within 0.15 to 0.10 of the tcd.Additional information was requested, however to date not provided.
Additional Manufacturer Narrative
Plant investigation: a product history review was performed.A review of the complaint management system identified no additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.20hxac092 indicated that 2238 cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20hxac092 met release specifications.As of 12/3/20, there were no samples available for return, however, the retain was pulled and tested through a special test request.All analytes were found to be within specifications.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed and a cause was not established.

• Brand Name: NATURALYTE 2251 2K 2.5CA 1MG GAL
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): OREGON MANUFACTURING PLANT; director, quality systems; 750 n lallendorf road; oregon OH 43616
• MDR Report Key: 10906679
• Report Number: 3005162618-2020-00021
• Device Sequence Number: 14260051
• Product Code: KPO
• UDI-Device Identifier: 00840861101696
• UDI-Public: 00840861101696
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 06/30/2022
• Device Model Number: 08-2251-0
• Device Catalogue Number: 08-2251-0
• Device Lot Number: 20HXAC092
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1