MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2201 2K 2.0CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-2201-5
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2020
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 hemodialysis (hd) clinic products coordinator reported to fresenius customer service that a lot of naturalyte had low conductivity.It was reported that 4 machines were not running properly during pretreatment setup and after doing a test they realized it was not the machines but a specific lot number of naturalyte.Upon follow up, the customer said that during patient treatment, the conductivity was at 13-13.1 and tcd 13.6 on a fresenius hd machine, resulting in a low conductivity alarm.The fresenius hd machine was swapped out for a phoenix machine, which had no conductivity alarms.This occurred during a patient's treatment.The patient completed treatment with the product and did not experience any ill effects or adverse events and that it was 4 jugs that were affected.Per the clinic, they have used naturalyte lot 20ntac054 without any issues and the machines have not have any recent service.The clinic uses bibags with lots ending in 2-7170 and 2-6101.A return goods authorization (rga) was issued to the clinic for product return.
Additional Manufacturer Narrative
Additional information: d10, h3 plant investigation: a product history review was performed.A review of the complaint management system identified 10 additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.20nxac014 indicated that 4486 cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20nxac014 met release specifications.As of 11/20/2020 no samples were returned.Samples are not needed to confirm the allegation.The 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 20nxac014 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20nxac014 release testing was found to be compromised due to the deficient test method.A non-conformance was opened for allegations of conductivity issues and escalated to a corrective action preventative action (capa).The total number of complaints for this lot met the threshold, however, due to the aforementioned capa, no other actions were taken.Based on the investigation performed, cause was traced to manufacturing.

• Brand Name: NATURALYTE 2201 2K 2.0CA 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: 10906794
• Report Number: 3005162618-2020-00013
• Device Sequence Number: 19540365
• Product Code: KPO
• UDI-Device Identifier: 00840861101672
• UDI-Public: 00840861101672
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: 08-2201-5
• Device Catalogue Number: 08-2201-5
• Device Lot Number: 20NXAC014
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1