MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 4231 4K 2.25CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-4231-0
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the customer reported that samples were available for return, however as of (b)(6) 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 oregon and irving laboratories.And results were found to be conflicting.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 20lxac052 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 (b)(6) 2020 did not identify any additional reported events for lot no.20lxac052 related to conductivity issues a review of the product inventory records for lot no.20lxac052 indicated that 2163 cases of finished product were manufactured on 9/21/2020 for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20lxac052 met release specifications.In conclusion, 20lxac052 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 setup, the conductivity was at 13.2ms/cm.The theoretical conductivity value (tcd) setting on the machine was not provided and the difference between actual conductivity is unknown.No patients were treated with the lot.Per the biomed, 2 jugs were affected and they had 6 jugs total.The biomed reported that there was no service to the machines and that they use bicarbonate rx12.A return goods authorization (rga) was issued to the clinic for product return.

• Brand Name: NATURALYTE 4231 4K 2.25CA 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: 10924428
• Report Number: 3005162618-2020-00036
• Device Sequence Number: 2127488
• Product Code: KPO
• UDI-Device Identifier: 00840861101801
• UDI-Public: 00840861101801
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/30/2020

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: 08-4231-0
• Device Catalogue Number: 08-4231-0
• Device Lot Number: 20LXAC052
• 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: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1