MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT CONSOLE; INSUFFLATOR, HYSTEROSCOPIC

Model Number FM3148G22D0

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

Fluent fluid management machine unreliable during procedure.The recorded deficit was inaccurate and the collection bag malfunctioned.The machine was zeroed out and reset with a deficit limit set to 2000.The machine reported a deficit of 4800 which exceeded the preset limit.Machine removed from service and company notified.

• Brand Name: FLUENT CONSOLE
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 17744316
• MDR Text Key: 323385670
• Report Number: 17744316
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2023

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: FM3148G22D0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Sex: Female