MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2301 2K 3.0CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-2301-3
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
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 inventory technician reported that a batch of naturalyte acid concentrate was defective and resulting in conductivity levels outside of the expected range.Upon follow up with the user facility administrator it was reported they did not have patient information, the lot involved, nor the exact date of the event.They indicated they would have to look for that information.They confirmed that the low conductivity level was found during treatment and was reading somewhere in the high 12 ms/cm, yet well outside of the range to cause the fresenius k2 hemodialysis machine to alarm.The patient receiving treatment was able to continue treatment after the nephrologist was contacted and the acid was switched to a different unknown acid.The remaining jugs of the reported lot was sequestered and scheduled to be picked up and returned by fmc customer service.They confirmed there were no adverse events, serious injuries, nor required medical intervention for the patients involved.The clinic uses naturalyte bicarb (unknown lot).Additional information was requested, however, a response was not received.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.There were a total of five lots of the reported product shipped to the customer during that time frame.A product history review was performed on the five lots.A review of the complaint management system did not identify any additional complaints related to conductivity issues with the reported lots.After reviewing the finished product release summary, it was determined that all the lots met release specifications and no non-conformances were identified that could be associated with the reported event.A review of the dhr did not reveal a probable cause for the customer complaint.Sample retains of the reported lots were tested and found to be within specifications.A definitive conclusion regarding the reported incident could not be reached and a cause could not be determined.
Event or Problem Description
A user facility inventory technician reported that a batch of naturalyte acid concentrate was defective and resulting in conductivity levels outside of the expected range.Upon follow up with the user facility administrator it was reported they did not have patient information, the lot involved, nor the exact date of the event.They indicated they would have to look for that information.They confirmed that the low conductivity level was found during treatment and was reading somewhere in the high 12 ms/cm, yet well outside of the range to cause the fresenius k2 hemodialysis machine to alarm.The patient receiving treatment was able to continue treatment after the nephrologist was contacted and the acid was switched to a different unknown acid.The remaining jugs of the reported lot was sequestered and scheduled to be picked up and returned by fmc customer service.They confirmed there were no adverse events, serious injuries, nor required medical intervention for the patients involved.The clinic uses naturalyte bicarb (unknown lot).Additional information was requested, however, a response was not received.

• Brand Name: NATURALYTE 2301 2K 3.0CA 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: 11603171
• Report Number: 3005162618-2021-00015
• Device Sequence Number: 4150586
• Product Code: KPO
• UDI-Device Identifier: 00840861101702
• UDI-Public: 00840861101702
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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 Model Number: 08-2301-3
• Device Catalogue Number: 08-2301-3
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/19/2021
• 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 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE