MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT CITRASATE ACID CONC. K2, CA2.5 4/CS; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	CITRASATE ACID CONC. K2, CA2.5 4/CS
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2020
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
It was reported a biomedical technician (bmt) received low conductivity values on a hemodialysis (hd) machine with a lot of citrasate acid.Upon follow up, the bmt clarified that the event occurred while testing the citrasate prior to patient treatment.The machine alarmed low conductivity and displayed a conductivity value of 13.1 ms/cm.The theoretical conductivity value was set to 13.5 ms/cm.She confirmed that this test was the first time the reported lot had been used.The remaining jugs of this lot were sequestered and were not used.The biomed is unsure which part or lot number of acid was used successfully after the reported incident.The clinic uses bibags bi-carbs (unknown part and lot number).There are four cases of the reported lot remaining at the clinic.The bmt indicated samples are available to return.A pickup was scheduled to return a sample.
Additional Manufacturer Narrative
Corrected information: d4- removed model # (transcription error) additional information: d10, h3 plant investigation: a product history review was performed.A review of the complaint management system identified no additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.20jxac012 indicated that 2029 cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20jxac012 met release specifications.As of 12/17/2020 no samples were returned.A sample retain was pulled and tested through a special test request.All analytes were found to be within specifications.Because of this, the allegation of conductivity low could not be confirmed and a cause was not established.

• Brand Name: CITRASATE ACID CONC. K2, 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: 11058518
• Report Number: 3005162618-2020-00190
• Device Sequence Number: 2975095
• Product Code: KPO
• UDI-Device Identifier: 00840861101344
• UDI-Public: 00840861101344
• 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,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 07/31/2022
• Device Model Number: CITRASATE ACID CONC. K2, CA2.5 4/CS
• Device Catalogue Number: 08-2251-CA
• Device Lot Number: 20JXAC012
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1