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

Model Number FLT-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Edema (2020)

Event Date 07/16/2021

Event Type  Injury  

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 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
• Type of Device: 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 jos?, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12308626
• MDR Text Key: 266056867
• Report Number: 1222780-2021-00224
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLUEN FLUID MANAGEMENT SYSTEM FLT-112S
• Patient Outcome(s): Hospitalization; Other