MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 3251 3K 2.5CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-3251-9
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2020
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 biomedical technician reported to fresenius customer service that they had a naturalyte lot that resulted in low conductivity values.Upon follow up the registered nurse (rn) confirmed the reported event and reported that the incident occurred with an unspecified number of machines on unknown dates.She confirmed that in all cases where they experienced conductivity issues during treatment, all the patients were able to complete their treatment after switching the jugs of naturalyte mid-treatment.There were no adverse events, serious injuries, nor required medical intervention as a result of these events.They are currently using bibags bi-carb.Sample return pickup was scheduled.This record captures all of the clinics unspecified number of incidents of low conductivity experienced during treatment while utilizing the reported batch.The event date for the multiple occurrences will be captures as (b)(6) 2020.
Additional Manufacturer Narrative
Additional information: d10, h3 plant investigation: a product history review was performed.A review of the complaint management system identified 8 additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no: 20lxac079 indicated that 4480 cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20lxac079 met release specifications.As of 11/12/2020, 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: 20lxac079 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20lxac079 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 3251 3K 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: 10933337
• Report Number: 3005162618-2020-00183
• Device Sequence Number: 3186724
• Product Code: KPO
• UDI-Device Identifier: 00840861101740
• UDI-Public: 00840861101740
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 08-3251-9
• Device Catalogue Number: 08-3251-9
• Device Lot Number: 20LXAC079
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/02/2020
• 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