MAUDE Adverse Event Report: MEDIVATORS INC. CENTRISOL ACID CONCENTRATE

Model Number	SB-352
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris is not the manufacturer of the centrisol acid concentrate subject of the reported event.Steris has notified the manufacturer, rockwell medical, of the reported event to internally investigate and evaluate for reportability.Steris is submitting this report solely in response to the received medwatch.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch mw5159069 that "concern about look alike labels for dialysis acid solutions from outset medical.The 2k and 3k acid baths have the same white writing on otherwise identical red background labels.It would be easy to mix up the solutions during storage and create a possible error." no report of injury.

• Brand Name: CENTRISOL ACID CONCENTRATE
• Common Device Name: CENTRISOL ACID CONCENTRATE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20480232
• Report Number: 2150060-2024-00055
• Device Sequence Number: 15555067
• Product Code: FKQ
• UDI-Device Identifier: 00677964044281
• UDI-Public: (01)00677964044281(17)230705(10)591951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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 Model Number: SB-352
• Device Lot Number: (10)591951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown