MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2201 2K 2.0CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-2201-5
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: a product history review was performed.A review of the complaint management system identified 10 additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.20nxac014 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 20nxac014 met release specifications.As of 11/20/2020, 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#: 20nxac014 did not meet release specifications, and the allegation conductivity low was confirmed.In conclusion, 20nxac014 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 hemodialysis (hd) clinic biomedical technician (biomed) reported to fresenius customer service that a lot of naturalyte had low conductivity values.Upon follow up, the biomed reported that during patient use, the conductivity was at 12.7 ms/cm.The theoretical conductivity parameter on the machine was not reported.Per the biomed, they switched to naturalyte lot#: 19ntac083 in the middle of treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.Per the biomed, 8 cases of the product are affected.The biomed reported that there was no service to the machines, and that they use bicarbonate naturalyte 4000rx12, lot 20ltbc001.A return goods authorization (rga) was issued to the clinic for product return.

• Brand Name: NATURALYTE 2201 2K 2.0CA 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: 10932816
• Report Number: 3005162618-2020-00174
• Device Sequence Number: 11559819
• Product Code: KPO
• UDI-Device Identifier: 00840861101672
• UDI-Public: 00840861101672
• 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
• Report Date (Section B): 12/02/2020

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: 08-2201-5
• Device Catalogue Number: 08-2201-5
• Device Lot Number: 20NXAC014
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1