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)
Date of Event	08/02/2024
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 noted.
Event or Problem Description
The user facility reported via medwatch report mw5157961 that their sb-352 and sb-353 jugs of centrisol acid concentrate had the same color and style labels.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: 20304390
• Report Number: 2150060-2024-00048
• Device Sequence Number: 15359532
• Product Code: FKQ
• UDI-Device Identifier: 00677964044281
• UDI-Public: (01)00677964044281(11)231218(10)610800
• 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): 09/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: SB-352
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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