MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT CITRASATE ACID CONC. K3, CA2.5 4/CS; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-3251-CA
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/18/2021
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 reported to technical support that a 2008t machine showed low conductivity levels when using a 3k citrasate acid concentrate during setup for hemodialysis (hd) treatment.The actual conductivity levels were 12.9 - 13.0 ms/cm with the theoretical conductivity value of 13.5 ms/cm.There was no patient involvement.Upon follow up with a user facility registered nurse (rn) it was reported that other machines that used jugs from the same box did not experience the reported conductivity issue.He indicated that the machine involved in the event had low conductivity results with jugs from different boxes.The rn indicated he suspects the cause of the reported issues is the machine and not the products.Multiple attempts were made to reach the bmt, but not response was received.
Additional Manufacturer Narrative
Corrected information: d11- removed due to no patient involvement.Plant investigation: the lot number of the product is unknown.A product history review was performed for the lots shipped to the customer within three months of the event date.A review of the complaint management system identified 2 additional complaints related to conductivity issues with the shipped lot, 20lxac051.There were no additional complaints reported on the other two lots, 20pxac041 or 20jxac094.A review of the product inventory records for these lot no.Did not identify any nonconformances.After reviewing the finished product release summary, it was determined that all three lots met release specifications.As of 12/16/2021 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 of lot 20lxac051.The tests at both the oregon and irving laboratories 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 20lxac051 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20lxac051 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 reported to technical support that a 2008t machine showed low conductivity levels when using a 3k citrasate acid concentrate during setup for hemodialysis (hd) treatment.The actual conductivity levels were 12.9 - 13.0 ms/cm with the theoretical conductivity value of 13.5 ms/cm.There was no patient involvement.Upon follow up with a user facility registered nurse (rn) it was reported that other machines that used jugs from the same box did not experience the reported conductivity issue.He indicated that the machine involved in the event had low conductivity results with jugs from different boxes.The rn indicated he suspects the cause of the reported issues is the machine and not the products.Multiple attempts were made to reach the bmt, but not response was received.

• Brand Name: CITRASATE ACID CONC. K3, CA2.5 4/CS
• 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: 11276610
• Report Number: 3005162618-2021-00003
• Device Sequence Number: 14701682
• Product Code: KPO
• UDI-Device Identifier: 00840861101351
• UDI-Public: 00840861101351
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 08-3251-CA
• Device Catalogue Number: 08-3251-CA
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE