MAUDE Adverse Event Report: MEDIVATORS CENTRISOL HEMODIALYSIS ACID CONCENTRATE; CENTRISOL HEMODIALYSIS CONCENTRATE

Model Number	SB-143
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported positive detection of oxidizing agents in their dialysate using centrisol acid concentrate lot 489224.Further customer testing confirmed the presence of oxidizing agents in the centrisol acid concentrate.Investigations performed by medivators on returned products confirmed that a limited subset of bottles from the impacted lot contain an out-of-specification concentration formulation due to the presence of an oxidizing agent.A recall of all products from the impacted lot will be conducted and the situation will be communicated to impacted customers.The use of out-of-specification formulations of the concentrate may present a risk when used in patient procedures.However, both test strip usage and conductivity checks are indicated as standard clinical practice and would make the situation detectable to the user.No harm has been reported as a result of this situation.Medivators has opened capa-(b)(4).To address this situation.Medivators will continue to monitor for similar events to ensure the product performs as expected.
Event or Problem Description
The user facility reported positive detection of oxidizing agents in their dialysate using centrisol acid concentrate lot 489224.Further customer testing confirmed the presence of oxidizing agents in the centrisol acid concentrate.No harm has been reported as a result of this situation.

• Brand Name: CENTRISOL HEMODIALYSIS ACID CONCENTRATE
• Common Device Name: CENTRISOL HEMODIALYSIS CONCENTRATE
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 11718016
• Report Number: 2150060-2021-00006
• Device Sequence Number: 1020531
• Product Code: FKQ
• UDI-Device Identifier: 00677964000577
• UDI-Public: 00677964000577
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K843963
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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-143
• Device Lot Number: 489224
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/23/2021
• 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: Other