MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT MANGEMENT SYSTEM; HYSTEROSCOPE (AND ACCESSORIES)

Model Number FLT-112S

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  malfunction  

Event Description

Nurse attempted to place the yellow outflow pack onto system, but it never recognized it.The nurse turned the machine on and off and attempted to place it again, but again it did not work.The nurse opened a second pack, and the blue inflow pack was leaking water.A third pack was opened, and the device worked successfully.I spoke with the rep and she said that she would send a replacement for the two flow packs.Fda safety report id # (b)(4).

• Brand Name: FLUENT MANGEMENT SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 12882945
• MDR Text Key: 281397718
• Report Number: MW5105611
• Device Sequence Number: 2
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1