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	Electrolyte Imbalance (2196); Loss of consciousness (2418)
Date of Event	12/11/2018
Type of Reportable Event	Serious Injury
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 loss of consciousness and metabolic acidosis requiring hospitalization.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 found unresponsive during their hd treatment on (b)(6) 2018.Upon follow up, the dt stated that 1.5 hours after the initiation of their treatment, the patient was found unresponsive.Emergency medical services (ems) were called and the patient was transported to the emergency room (er).The dt stated that hematological studies conducted in the er revealed that the patient was in metabolic acidosis with a sodium (na) level of 172 and a ph of 7.1.The dt stated that the patient remained hospitalized as of (b)(6) 2018.Additional patient, intervention, event, and hospitalization details were requested, but were not provided.No sample was available for manufacturer analysis.

• 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: 8189256
• Report Number: 3005162618-2018-00010
• Device Sequence Number: 13952518
• 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
• Report Date (Section B): 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 13-2251-0
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/21/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention