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	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product investigation: customer reported that (b)(4) manufacturing facility product naturalyte 3251 2k 2.5ca 1mg gal product no.08-3251-9 lot no.20lxac078 would not come up to conductivity.For the product history review, a review of the complaint management system on 11/25/2020 identified 5 additional reported events for lot no.20lxac078 related to conductivity issues.A review of the product inventory records for lot no.20lxac078 indicated that (b)(4) cases of finished product were manufactured on 9/22/2020 for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20lxac078 met release specifications.As of 11/20/2020, there were no samples available for return, however these samples are not needed to confirm this 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 (b)(6) and (b)(6) laboratories.Due to the conflicting results found between the laboratories, the (b)(6) 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 20lxac078 did not meet release specifications and the allegation low conductivity was confirmed.In conclusion, 20lxac078 release testing was found to be compromised due to the deficient test method.A non-conformance (nc) was opened and escalated to capa for the reported event.Further investigation for this issue will be carried out through the capa.Based on the investigation performed, cause was traced to manufacturing.
Event or Problem Description
A hemodialysis (hd) clinic biomedical technician (biomed) reported by fax that some naturalyte would not come up to conductivity.Upon follow up, the customer said that before use, the conductivity was at 10.6 ms/cm.The biomed stated that 20 gallons are effected.The product was not used for patient treatment.The biomed reported that there was no recent service to any of the machines.The facility was using naturalyte bicarbonate (lot 20kxbc006).The customer has not been in touch with customer service to obtain a returns good authorization (rga) for product return.

• 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: 10927219
• Report Number: 3005162618-2020-00115
• Device Sequence Number: 19450266
• Product Code: KPO
• UDI-Device Identifier: 00840861101740
• UDI-Public: 00840861101740
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 20LXAC078
• 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: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1