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

Model Number	FLT-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bronchospasm (2598); Hypervolemia (2664)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a fluent procedure on (b)(6) 2023, the fluid deficit stayed at a certain number during the procedure and the staff did not realize it , thus the patient received a fluid overload estimated at around 2 liters.Patient became unstable due to bronchospasm and after the surgery presented with cough.Due the patient exhibiting symptoms of fluid overload it was admitted to the intensive care unit and received a chest x-ray and treatment with steroids and diuretics.The patient was discharged after several days and is recovering well.The console was examined and tested and it was found within tolerance limit.No other information is available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The console was examined and tested and it was found within tolerance limit.A load cell calibration was performed and it was found within normal limits.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18092013
• Report Number: 1222780-2023-00419
• Device Sequence Number: 15123636
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552(11)220201
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K180825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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: FLT-100
• Device Catalogue Number: FLT-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown