MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2301 2K 3.0CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-2301-3
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: as of 11/12/20, there were samples were not returned, however, samples are not needed to confirm the allegation.Through other complaint allegations of the same issue for lots: 20lxac056, 20lxac058, and 20lxac076, there were companion samples available for testing which were tested at both the oregon and irving laboratories, which had conflicting results.Due to the conflicting results found between the laboratories, the oregon test methods were reviewed and a deficiency was found in the test method pertaining to the sodium and potassium analyte tests.Because of the deficiency found in the test method, it was determined that lot#: 20nxac013 did not meet release specifications and the allegation of conductivity low was confirmed.A product history review was performed.A review of the complaint management system on (b)(6) 2020 identified 6 additional reported events for lot no.20nxac013 related to conductivity issues.A review of the product inventory records for lot no.20nxac013 indicated that 2357 cases of finished product were manufactured on 10/7/20 for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20nxac013 met release specifications.In conclusion, 20nxac013 release testing was found to be compromised due to the deficient test method.A non-conformance was already opened for allegations of conductivity issues and escalated to a corrective action, preventative action.Based on the investigation performed, cause was traced to manufacturing.
Event or Problem Description
A hemodialysis (hd) biomedical technician (biomed) reported to fresenius customer service that a lot of naturalyte had low conductivity.Upon follow up, the biomed reported that before use, the conductivity was at or below the lower theoretical conductivity (tcd) limit.No patients were treated with the product.The biomed stated that more than one jug was affected, however, did not specify the amount.Per biomed they have successfully used naturalyte lots: 20nxac013 and 20lxac038.The biomed reported that there was no service to the machines and that they use bicarbonate naturalyte rx-12, lot : 20hxbc010.

• Brand Name: NATURALYTE 2301 2K 3.0CA 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: 10932562
• Report Number: 3005162618-2020-00159
• Device Sequence Number: 19658024
• Product Code: KPO
• UDI-Device Identifier: 00840861101702
• UDI-Public: 00840861101702
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 12/02/2020

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: 10/31/2022
• Device Model Number: 08-2301-3
• Device Catalogue Number: 08-2301-3
• Device Lot Number: 20NXAC013
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1