MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2251 2K 2.5CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-2251-0
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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 biomedical technician (bmt) reported low conductivity alarms from a hemodialysis (hd) machine while utilizing a batch of naturalyte acid concentrate during testing.The machine conductivity value was reading 13.2 ms/cm and the theoretical conductivity value was 13.5 ms/cm.After calibrating the bicarbonate pump, acid pump, conductivity cells, and the balancing chamber, the conductivity levels remained at 13.2 ms/cm.The issue was resolved after changing the acid to different lot.Upon follow up, the bmt confirmed there was no patient involvement during the low conductivity values he observed.Upon follow up with the facility manager, it was indicated that there were no samples available for evaluation.The facility manager indicated that the reported batch was one of the lots listed on the voluntary recall list they received from fresenius.The lot number of the product was requested but is not available due to all product being discarded.
Additional Manufacturer Narrative
Plant investigation: a lot number was not provided.Based on the allegation that reported product¿s lot was on the voluntary recall list, a search was performed of the products shipped to the customer in the three months prior to the event date.Of the 10 lots, only lot # 20lxac091 was shipped and on the recall list.A product history review was performed.A review of the complaint management system didn¿t identify any additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for the lot indicated that (b)(4) cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20lxac091 met release specifications.As of 03/09/2021 no samples were returned.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 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 20lxac091 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20lxac091 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 biomedical technician (bmt) reported low conductivity alarms from a hemodialysis (hd) machine while utilizing a batch of naturalyte acid concentrate during testing.The machine conductivity value was reading 13.2 ms/cm and the theoretical conductivity value was 13.5 ms/cm.After calibrating the bicarbonate pump, acid pump, conductivity cells, and the balancing chamber, the conductivity levels remained at 13.2 ms/cm.The issue was resolved after changing the acid to different lot.Upon follow up, the bmt confirmed there was no patient involvement during the low conductivity values he observed.Upon follow up with the facility manager, it was indicated that there were no samples available for evaluation.The facility manager indicated that the reported batch was one of the lots listed on the voluntary recall list they received from fresenius.The lot number of the product was requested but is not available due to all product being discarded.

• Brand Name: NATURALYTE 2251 2K 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: 11324338
• Report Number: 3005162618-2021-00005
• Device Sequence Number: 19868340
• Product Code: KPO
• UDI-Device Identifier: 00840861101696
• UDI-Public: 00840861101696
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K192017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: Other
• Device Model Number: 08-2251-0
• Device Catalogue Number: 08-2251-0
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1