MAUDE Adverse Event Report: MEDIVATORS CENTRISOL LIQUID BICARBONATE CONCENTRATE; DIALYSIS CONCENTRATE FOR HEMODIALYSIS

Model Number	MB330-L-B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Renal Disease, End Stage (2039)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was received through medivators distributor, fresenius medical care (fmc) post market surveillance department.It was reported a female patient became unresponsive during a hemodialysis treatment.During follow up with the facility's nurse manager (nm), it was learned the patient had a past medical history of cardiac disease (unspecified), and end stage renal disease and has been on hemodialysis for approximately two years.The patient verbally reported to the nursing staff that she did not feel well close to the end of the treatment and became unresponsive.The treatment was stopped and the venous blood was returned.Reportedly, the arterial blood was not returned due to the nurse's need to immediately attend to the patient.Cardiopulmonary resuscitation was performed successfully.Hospitalization details were not provided.The patient has returned to hemodialysis and continues without further issue.The physician stated he believed the patient's cardiac history was the cause of the event.Centrisol liquid bicarbonate was in use at the time of the event.Lot numbers were not provided.Medivators ra followed up with this facility for additional information.It was confirmed by the facility that no lot information was documented, thus there is no product returned for further investigation.The device was reported to have been used properly and there have been no other reported patient illness or injury with the liquid bicarbonate they received from medivators.Medivators will continue to monitor this complaint within medivators complaint handling system.
Event or Problem Description
It was reported that a female patient became unresponsive during receipt of hemodialysis treatment.Centrisol liquid bicarbonate was used in the dialysate solution for dialysis treatment of this patient.

• Brand Name: CENTRISOL LIQUID BICARBONATE CONCENTRATE
• Common Device Name: DIALYSIS CONCENTRATE FOR HEMODIALYSIS
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6231076
• Report Number: 2150060-2017-00002
• Device Sequence Number: 966842
• 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: K843963A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring,Inspection
• Type of Report: Initial
• Report Date (Section B): 01/06/2017

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: No Information
• Device Model Number: MB330-L-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/06/2017
• 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: Hospitalization; Life Threatening; Required Intervention