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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
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 that a 2008t hemodialysis (hd) machine was alarming low conductivity while utilizing a low sodium batch of naturalyte during setup.Upon follow up, the bmt confirmed he observed the low conductivity alarm and values on one machine during setup.The theoretical conductivity (tcd) was 13.7 ms/cm and the actual conductivity was bouncing between 13.2 ¿ 13.3 ms/cm.The issue was resolved after replacing the naturalyte with lot # 20cxa3044.He confirmed there was no patient involvement.The bi-bicarb used was part # 08-4080-bb, lot # is unknown.There were 6 gallons remaining of the reported naturalyte lot when the issue occurred.He is unsure if the clinic has used the remaining jugs.The bmt indicated he would follow up if samples were available to return for physical evaluation.There were no serious adverse events, injuries, nor required medical intervention attributed to this event.
Additional Manufacturer Narrative
Plant investigation: a product history review was performed.A review of the complaint management system identified 6 additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.20lxac059 indicated that 2140 cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20lxac059 met release specifications.As of 03/02/2021 no samples were returned.Samples are not needed to confirm the allegation.A sample retain of the reported lot 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: 20lxac059 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20lxac059 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 that a 2008t hemodialysis (hd) machine was alarming low conductivity while utilizing a low sodium batch of naturalyte during setup.Upon follow up, the bmt confirmed he observed the low conductivity alarm and values on one machine during setup.The theoretical conductivity (tcd) was 13.7 ms/cm and the actual conductivity was bouncing between 13.2 ¿ 13.3 ms/cm.The issue was resolved after replacing the naturalyte with lot#: 20cxa3044.He confirmed there was no patient involvement.The bi-bicarb used was part#: 08-4080-bb, lot# is unknown.There were 6 gallons remaining of the reported naturalyte lot when the issue occurred.He is unsure if the clinic has used the remaining jugs.The bmt indicated he would follow up if samples were available to return for physical evaluation.There were no serious adverse events, injuries, nor required medical intervention attributed to this event.

• 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: 11381713
• Report Number: 3005162618-2021-00010
• Device Sequence Number: 11728930
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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 Expiration Date: 09/30/2022
• Device Model Number: 08-3251-9
• Device Catalogue Number: 08-3251-9
• Device Lot Number: 20LXAC059
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1