MAUDE Adverse Event Report: MEDIVATORS, INC. CENTRISOL LIQUID BICARBONATE CONCENTRATE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS

Catalog Number	MB-330-L-B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Patient Problem/Medical Problem (2688)
Date of Event	07/10/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The report states: "the charge nurse at the user facility reported a patient adverse event that occurred soon after the hemodialysis (hd) treatment was initiated.Further event clarification revealed that approximately 10 minutes after initiation of the hd therapy the patient gasped, and then coded.The treatment was cancelled, and the patient was removed from the machine.The code continued for one hour and thirty minutes, after which time, the patient expired.Follow-up information was received which revealed that the event was believed to have been caused by a pulmonary embolism (pe).Although requested, no further patient specific or event related details have been made available.No machine alarms were generated prior to, during, or following the patient incident." medivators centrisol liquid sodium bicarbonate concentrate (45x) was being used in conjunction with naturalyte acid concentrate for the dialysate solution in a fresenius hemodialysis machine.Medivators distributor, (b)(4), received notice of this adverse event from the facility on 05/19/2017.Medivators received a complaint notification letter from (b)(4) on 07/10/2017.Both medivators and (b)(4) post market surveillance teams attempted to contact the facility for additional event information.This follow up information reported that the event was caused by a pulmonary embolism (pe).It was also reported that no dialysis machine alarms were generated prior to, during, or following the patient incident.In these attempts, the lot number of the bicarbonate used or any patient related information was not provided/disclosed.This complaint will continue to be monitored in medivators complaint system.
Event or Problem Description
User facility reported that during a hemodialysis treatment, the patient gasped, and then coded.After cancelling the treatment and removing the patient from the machine, the code continued for one hour and thirty minutes, after which time, the patient expired.It was reported that the adverse event was caused by a pulmonary embolism (pe).Medivators liquid bicarbonate was used in the dialysate solution for dialysis treatment.

• Brand Name: CENTRISOL LIQUID BICARBONATE CONCENTRATE
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6765625
• Report Number: 2150060-2017-00033
• Device Sequence Number: 1947664
• Product Code: KPO
• UDI-Device Identifier: 00677964000409
• UDI-Public: 00677964000409
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K843963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: MB-330-L-B
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/03/2017
• 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: Death