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 Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
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 user facility biomedical technician (bmt) reported that a lot of naturalyte concentrate acid had caused the hemodialysis (hd) machine to alarm low conductivity during hd treatment.They switched the concentrates and were able to continue treatment.Upon follow up, the bmt confirmed that no adverse events were experienced and no medical intervention was required as a result of the reported event.The treatment was completed with the same machine after switching to a different lot of naturalyte acid.He indicated that the lot of naturalyte they used was labeled low sodium, but they were not aware at the time of setup.The bmt indicates that the cause of the low conductivity was a step that was missed with the bicarb after the acid was fed to the treatment area.They were able to complete more treatments with the same lot of naturalyte without experiencing any low conductivity issues.
Event or Problem Description
A user facility biomedical technician (bmt) reported that a lot of naturalyte concentrate acid had caused the hemodialysis (hd) machine to alarm low conductivity during hd treatment.They switched the concentrates and were able to continue treatment.Upon follow up, the bmt confirmed that no adverse events were experienced and no medical intervention was required as a result of the reported event.The treatment was completed with the same machine after switching to a different lot of naturalyte acid.He indicated that the lot of naturalyte they used was labeled low sodium, but they were not aware at the time of setup.The bmt indicates that the cause of the low conductivity was a step that was missed with the bicarb after the acid was fed to the treatment area.They were able to complete more treatments with the same lot of naturalyte without experiencing any low conductivity issues.
Additional Manufacturer Narrative
Plant investigation: a product history review was performed.A review of the complaint management system identified 16 additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.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 20nxac026 met release specifications.As of (b)(6) 2020 no samples were returned.Samples are not needed to confirm the allegation.Low conductivity is a known issue for the oregon manufacturing facility that was investigated through a capa.An action was implemented in which lots that met a certain criteria, including a sodium value that was less than 6% from nominal, were tagged with a ¿low sodium¿ label so that the clinic could make an adjustment prior to treatment.The capa was initiated due to conflicting laboratory results found at the irving and oregon 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 20nxac026 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20nxac026 release testing was found to be compromised due to the deficient test method.Based on the investigation performed, cause was traced to manufacturing.

• 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: 11363236
• Report Number: 3005162618-2021-00008
• Device Sequence Number: 2581212
• Product Code: KPO
• UDI-Device Identifier: 00840861101740
• UDI-Public: 00840861101740
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: health professional
• 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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 08-3251-9
• Device Catalogue Number: 08-3251-9
• Device Lot Number: 20NXAC026
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/22/2021
• 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