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

Model Number	FLT-200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762); Sepsis (2067)
Date of Event	05/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a myosure reach and fluent pro on (b)(6) 2026, the patient went into cardiac arrest and had to be resuscitated.Patient had a previous history of retained products of conception and additionally had been admitted to the hospital over the weekend due to sepsis following 2 suction dilatation and curettage the previous weekend.5 minutes into the procedure while being under anesthesia the patient had sudden desaturation and cardiovascular collapse.The team was able to successfully resuscitate and stabilize the patient.The deficit at the time of the cardiovascular collapse was reading 3065 ml with staff estimating approximately 1000 ml of spillage on the floor.When the patient went into cardiac arrest the patient lacked pulse and oxygen for one minute.During the procedure the patient´s oxygen saturation dropped to 30%, prompting the anesthesiologist to call for a crash cart.To accommodate the emergency equipment the fluent procedure was ended, pushed away from the patient.An abdominal ultrasound was performed by a non-scrubbed surgeon which revealed no internal fluid accumulation.At the time total fluid read at 5845 ml.Cutting time was 4 minutes and 29 seconds.Staff called for x-ray and the anesthesiologist started lasix and a foley catheter.Physician confirmed that the system had given the high-fluid loss alarm at around 400ml and that the deficit limit had been reached at 2500ml.They were able to remove the retained products of conception.The patient was admitted overnight and was stable.It was later reported by the physician that the patient had a ¨fluid embolism and precipitously desaturation ¨.The patient was later reported as doing well and fever was gone, all the septic tissue was removed and the patient was doing well.
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.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

• Brand Name: FLUENT PRO 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 park zone b24; alajuela 20102
• MDR Report Key: 25446816
• Report Number: 1222780-2026-00369
• Device Sequence Number: 13150838
• Product Code: HIG
• UDI-Device Identifier: 15420045516212
• UDI-Public: (01)15420045516212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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-200
• Device Catalogue Number: FLT-200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown