MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE DRY PACK RX-12; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	08-4112-2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: the actual device was not returned to the manufacturer for physical evaluation.A review of the process controls in place showed all product analysis and check weigher system requirements were met.The retain sample was pulled and tested for the lot number.The retain was tested for bicarbonate analysis and sodium analysis.All results were found to be within specification.The bicarbonate concentration was found to be 978.1 meq/l, which is within the 943.8 ¿ 992.2 meq/l specification.The sodium concentration was found to be 955.0 meq/l, which is within the 943.8 ¿ 992.2 meq/l specification.Furthermore, there is no out specification for specific gravity or conductivity called out in the release criteria for the manufacturer.A records review was performed on the reported lot number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all acceptance criteria, and no adverse events were noted during production related to the filler, check weigher, and/or product laboratory analysis.The investigation into the cause of the reported problem was not able to be confirmed and the probable cause of this event is unknown.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
It was reported that a patient experienced nausea during hemodialysis treatment.A biomed technician reported that the batch of naturalyte was mixed improperly and caused the symptoms in the patient.During follow up with the biomed technician it was reported that the naturalyte was mixed during the morning shift, and was possible there were incorrect quantities mixed.There were no alarms.The conductivity of the machine was checked and read 13.0-13.1.The clinic manager stated that the patient was able to complete treatment.The clinic manager stated that a blood test was performed and revealed that the bicarbonate levels were significantly lowered.
Additional Manufacturer Narrative
The file was assessed for the need of a clinical investigation.A bio-medical technician reported a patient experienced even(s) of nausea, headache, lightheadedness, diaphoresis and feeling hot during an outpatient hemodialysis (hd) treatment.The hd treatment record indicates the patient experienced nausea approximately 2.25 hours into treatment, however there is no documented medical intervention.The patient completed 2.75 hours of a 3.5 hour hd treatment, however the treatment record does not indicate the specific rational for the early termination.The retained sample of this batch of naturalyte was tested and all results were found to be within manufacturer specifications.There is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.Therefore the completion of a clinical investigation is not required.Should additional information become available, the need for a clinical investigation will be reassessed.

• Brand Name: NATURALYTE DRY PACK RX-12
• 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: 7443772
• Report Number: 3005162618-2018-00004
• Device Sequence Number: 1055186
• Product Code: KPO
• UDI-Device Identifier: 00840861101955
• UDI-Public: 00840861101955
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K981043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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 Expiration Date: 01/31/2020
• Device Catalogue Number: 08-4112-2
• Device Lot Number: 18AXBC005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 112