MAUDE Adverse Event Report: IRRIMAX CORPORATION IRRISEPT ANTIMICROBIAL WOUND LAVAGE; JET LAVAGE

Model Number	ISEPT-450-USA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was reported to the manufacturer on 04mar2025 (event occurrence was during year 2022 - exact date unknown).Contact with the or director found that the product has been used consistently for approximately 3 years.While the reported patient condition can develop with cardiac procedures and no direct correlation to the product has been identified, the event was assessed to qualify as a reportable event and is lodged for completeness.This report is based upon information provided to the manufacturer.Blank fields indicate that the information was not provided by physician reporting the event, was not available, or was not applicable.This report does not constitute an admission to or conclusion by fda, the manufacturer, or its employees or agents that the device, the manufacturer, or its employees or agents caused, contributed in any way to, or any way is connected with the event(s) described in this report.The previous paragraph shall be included in any information or report disclosed to the public including information or reports provided under the freedom of information act.
Event or Problem Description
On (b)(6) 2025, it was reported that a patient underwent cardiac surgery where irrisept was used for irrigation.According to the event information provided, the product was used in the procedure and due to the surgical conditions present, the fluid was believed to have come into contact with the patient intravascularly.The patient presented increased values of lactic acid which was treated and resolved.It was also stated that these issues date back to 2022.No additional patient harm or intervention was required or reported.No other information about the patient was provided.Irrimax advised that irrisept should not be used when potential for intravascular injection is possible as the product labeling states "not for injection".

• Brand Name: IRRISEPT ANTIMICROBIAL WOUND LAVAGE
• Common Device Name: JET LAVAGE
• Manufacturer (Section D): IRRIMAX CORPORATION; 1665 lakes parkway, suite 102; lawrenceville, ga GA 30043 5879
• Manufacturer (Section G): MEDLINE INDUSTRIES (MUNDELEIN PACKAGING); 1 medline place; mundelein IL 60060
• Manufacturer Contact: rick holecek ; 1665 lakes parkway, suite 102; lawrenceville, GA 30043-1079 ; 7708078445
• MDR Report Key: 21756123
• Report Number: 3005706359-2025-00003
• Device Sequence Number: 21247367
• Product Code: FQH
• UDI-Device Identifier: 10842351190002
• UDI-Public: 10842351190002
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K210536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2025

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: ISEPT-450-USA
• Device Lot Number: UNKNOWN
• 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: 03/04/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown