MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 2251 2K 2.5CA 1MG 55 GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	13-2251-0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144); Diaphoresis (2452)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: a records review was performed to obtain all lot numbers delivered to the customer's facility three months prior to the complaint occurrence date, from (b)(6) 2018 thru (b)(6) 2018.The review revealed that the following lot numbers that potentially could be involved: 18nxac067, 18nxac040, 18nxac013, 18lxac082, 18lxac059, 18lxac057, 18lxac056, 18lxac042, 18lxac043 and 18kxac026.A device history records (dhr) review did not reveal any issue during the manufacturing process and all inspection and release criteria was met.Based on the results of the sap search and lack of product malfunctions reported within the information available in the complaint file, it is not possible to determine a cause related to the product manufacturing process.In conclusion, the complaint cannot be traced to the device as there are no product malfunctions and/or out of specifications reported.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, naturalyte #2251 - 2k 2.5ca 1mg and the serious adverse event(s) of nausea, vomiting and diaphoresis requiring discontinuation and re-initiation of hd therapy.The etiology of the event(s) is unknown; therefore, causality cannot be determined.Based on the information available, the naturalyte #2251 - 2k 2.5ca 1mg cannot be disassociated from the event(s).A sample of the naturalyte #2251 - 2k 2.5ca 1mg utilized on (b)(6) 2018 was not retained for manufacturer evaluation, therefore validation testing cannot be performed.Additionally, there is no record of functional compliance testing being performed on the 2008t hemodialysis system post event(s).Should additional information become available, the need for an amended clinical investigation will be re-evaluated accordingly.
Event or Problem Description
A user facility dialysis technician (dt) reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt) was feeling unwell during their hd treatment on (b)(6) 2018.Upon follow up, the dt stated that 30 minutes after the initiation of their treatment, the patient reported feeling unwell.Approximately 10-15 minutes later, the patient was diaphoretic, vomiting, and nauseous.The patient was moved to a new machine and treatment completed successfully with new supplies.There was no medical intervention necessary during the reported event and there was no serious injury to the patient.Additional patient, intervention, event, and hospitalization details were requested, but were not provided.
Additional Manufacturer Narrative
Correction: upon further investigation, it was determined that the event reported on this mdr is not a reportable event.There will be no further updates on mfr#: 3005162618-2018-00011.

• Brand Name: NATURALYTE 2251 2K 2.5CA 1MG 55 GAL
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): OREGON MANUFACTURING PLANT; 750 n lallendorf road; oregon OH 43616
• MDR Report Key: 8189321
• Report Number: 3005162618-2018-00011
• Device Sequence Number: 13928241
• Product Code: KPO
• UDI-Device Identifier: 00840861101863
• UDI-Public: 00840861101863
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K981043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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 Catalogue Number: 13-2251-0
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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