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 Patient Involvement (2645)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: a product history review was performed.A review of the complaint management system identified 8 additional reported events for lot no.20lxac079 related to conductivity issues.A review of the product inventory records for lot no.20lxac079 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 20lxac079 met release specifications.As of (b)(6) 2020 no samples were returned.Samples are not needed to confirm the allegation.A sample retain was tested 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).Based on the investigation performed, cause was traced to manufacturing.
Event or Problem Description
A hemodialysis (hd) clinic biomedical technician (bmt) reported to fresenius customer service that they received low conductivity values from a specific naturalyte batch on an hd machine.It was not specified if the machine was being used for treatment or was being setup when the low conductivity was detected.The machine alarmed for the low conductivity.Additionally, there was no information reported on the number of occurrences of these alarms and the dates.There was no reported adverse event or serious injury attributed to the allegation.Multiple attempts were made to acquire additional information; however, a response was not received.

• 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: 10932638
• Report Number: 3005162618-2020-00166
• Device Sequence Number: 3299337
• 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
• 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: 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
• 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