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

Model Number	FLT-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Edema (2020)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
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 device was received and evaluated by pmqa after being received and decontaminated through the rma process.Visual inspection was complete, the iv pole and blue handle were found to be loose.Initial power on, no issues were noted.A linearity test was performed.Both load cells remained within the allowable tolerance.A deficit accuracy test was performed.No problems warnings or errors were observed.The reported complaint was not confirmed.Hologic will continue to track and trend this event.Complaint could not be confirmed/reproduced, unable to establish relationship between the issue reported and the device.We will continue to trend and monitor the reported condition.
Event or Problem Description
It was reported that during a myomectomy that involved a fluent on july 16th, during the procedure the deficit jumped to 5000 and the staff had to perform a manual count.The procedure was completed and at the end of the procedure the manual count was 2500 ml.The patient had to be readmitted to the hospital after the surgery due to a pulmonary edema.No other information is available.

• Brand Name: FLUENT CONSOLE
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 12308626
• Report Number: 1222780-2021-00224
• Device Sequence Number: 14404576
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUEN FLUID MANAGEMENT SYSTEM FLT-112S
• Outcome Attributed to Adverse Event: Hospitalization; Other