MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT MACHINE: FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Model Number RM-FLT-100

Patient Problem Hypervolemia (2664)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

Infusion fluid went quickly to a deficit and a new bag was hung.Used 8600ml fluid, deficit 5935ml, 3031ml in waste bag, minimal fluid around patient.Pressure started at 80mmhg increased to 100mmhg during surgery.Patient had fluid overload and required diuretic.

• Brand Name: FLUENT MACHINE: FLUID MANAGEMENT SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 19003693
• MDR Text Key: 339059617
• Report Number: MW5153352
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Model Number: RM-FLT-100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Race: White