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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: as of 11/12/2020 no samples were returned.Samples are not needed to confirm the allegation.A sample retain was tested through a special test request and found to be within specifications.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 (b)(6) laboratories.And results were found to be conflicting.Due to the conflicting results found between the laboratories, the (b)(6) 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 20lxac041 did not meet release specifications and the allegation conductivity low was confirmed.A product history review was performed.A review of the complaint management system on 11/18/2020 identified 9 additional reported events for lot no.20lxac097 related to conductivity issues.The threshold for non-conformance was reached for lot 20lxac041 however a nonconformance was already initiated for this issue.A review of the product inventory records for lot no.20lxac041 indicated that (b)(4) cases of finished product were manufactured on 9/9/2020 for distribution with no additional noted non-conformances.After reviewing the finished product release summary, it was determined that 20lxac041 met release specifications.In conclusion, 20lxac041 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 (capa).Based on the investigation performed, cause was traced to manufacturing.
Event or Problem Description
A hemodialysis (hd) clinic biomedical technician (biomed) reported to fresenius customer service that a lot of naturalyte had low conductivity.Upon follow up, the biomed reported that during use, the conductivity was at 13.0 ms/cm.The theoretical conductivity value (tcd) setting on the machine was not provided and the difference between actual conductivity is unknown.The patient completed treatment with the product.The patient did not experience any adverse events or require medical intervention as a result of the reported event.Per the biomed, 12 jugs are affected.The biomed reported that there was no service to the machines and that they use bicarbonate naturalyte 4000rx12, lot number 20hxbc011.No samples were available to be returned to the manufacturer for physical evaluation.

• 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: 10925918
• Report Number: 3005162618-2020-00037
• Device Sequence Number: 2469817
• Product Code: KPO
• UDI-Device Identifier: 00840861101702
• UDI-Public: 00840861101702
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/01/2020

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: 09/30/2022
• Device Model Number: 08-2301-3
• Device Catalogue Number: 08-2301-3
• Device Lot Number: 20LXAC041
• 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: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1