MAUDE Adverse Event Report: IRRAS USA, INC. IRRAFLOW; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

I am deeply concerned about the inappropriate use of the irraflow intraventricular irrigation system within the department of (b)(6).The irraflow system is designed to provide dynamic intracranial pressure control via continuous irrigation and drainage of cerebrospinal fluid (csf) for treating conditions such as intraventricular hemorrhage and infection.However, recent evidence suggests its application at unm has resulted in unnecessary harm to multiple patients due to careless use, inadequate training of medical personnel, and possible design flaws.Please read below.Reports of severe infections, mechanical failures, and improper pressure settings causing intracranial pressure imbalances highlight the urgent need for proper training and guidelines to ensure safe and effective use of this device.Reference report mw5161124.

• Brand Name: IRRAFLOW
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): IRRAS USA, INC.
• MDR Report Key: 20471454
• MDR Text Key: 354517204
• Report Number: MW5161125
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/15/2024

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown