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 Patient Involvement (2645)
Date of Event	11/06/2020
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 user facility biomedical technician (bmt) reported via fax that the hemodialysis (hd) machines are having conductivity issues with the use of naturalyte.Upon follow up, the customer provided details of one low conductivity occurrence during treatment, however, specifics details on the low conductivity experienced by other machines were not provided.This record captures the alleged naturalyte batch low conductivity results experienced on the other machines.It is unknown if these occurrences were during treatment or setup.Five cases were affected.The bmt has not been in touch with customer service to return any affected product.No repairs to the machines were performed.The clinic uses naturalyte bicarbonate lot 20hxbc010.Additional information was requested, however, a response was not received.A sample return is not expected.
Additional Manufacturer Narrative
Plant investigation: as of 12/11/20, there were no samples available for return, however samples are not needed to confirm the allegation.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 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 20nxac035 did not meet release specifications and the allegation of conductivity low was confirmed.A product history review was performed.A review of the complaint management system on 12/16/2020 identified 2 additional reported events for lot no.20nxac035 related to conductivity issues.A review of the product inventory records for lot no.20nxac035 indicated that 6761 cases of finished product were manufactured on 10/19/20 for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20nxac035 met release specifications.In conclusion, 20nxac035 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 a corrective action.Based on the investigation performed, cause was traced to manufacturing.

• 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: 10933203
• Report Number: 3005162618-2020-00181
• Device Sequence Number: 11559963
• Product Code: KPO
• UDI-Device Identifier: 00840861101702
• UDI-Public: 00840861101702
• 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,Followup
• Report Date (Section B): 12/24/2020

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: 08-2301-3
• Device Catalogue Number: 08-2301-3
• Device Lot Number: 20NXAC035
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1