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 Code	Death (1802)
Date of Event	07/13/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
This complaint was received through medivators distributor, (b)(4) it was reported that a female patient expired while receiving hemodialysis.Medivators ra contacted this facility for additional information.In this discussion with the facility patient care director, it was confirmed that the device performed as expected and reported to have been used properly.It was documented that medivators centrisol liquid bicarbonate concentrate was used in the dialysate solution for this patient treatment.No lot information was documented.Medivators was unable to receive product back from the facility.The facility reported that the patient, (b)(6) woman with severe diabetes complicated by blindness was admitted in an unstable condition and slowly declining.She was dnr/dni.After 10 mins of cpr, the patients family told them to stop and patient expired.This complaint will continue to be maintained within medivators complaint system.
Event or Problem Description
A (b)(6) patient expired while receiving dialysis treatment.Medivators centrisol liquid bicarbonate concentrate was used in the dialysate solution for dialysis treatment on 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: 5822643
• Report Number: 2150060-2016-00030
• Device Sequence Number: 11070165
• Product Code: KPO
• UDI-Device Identifier: 30677964000400
• UDI-Public: 30677964000400
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K843963/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

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 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: 07/13/2016
• Initial Report FDA Received Date: 07/26/2016
• 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 HEMODIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR