MAUDE Adverse Event Report: GAMBRO LUNDIA AB BICART SODIUM BICARBONATE FOR HEMODIALYSIS; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	1250
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Black flecks floating in bicart after a hemodialysis treatment.

• Brand Name: BICART SODIUM BICARBONATE FOR HEMODIALYSIS
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): GAMBRO LUNDIA AB; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16635058
• Report Number: 16635058
• Device Sequence Number: 17673950
• Product Code: KPO
• UDI-Device Identifier: 07332414110574
• UDI-Public: 07332414110574
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/17/2023
• Report Date (Section F): 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1250
• Device Catalogue Number: 114014
• Device Lot Number: 240630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White
• Date Report Sent to FDA: 03/17/2023