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

Model Number	FLT-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypervolemia (2664)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that during the procedure, four times when an 800 ml fluid deficit was reached, the machine alarmed and zeroed out the device.Procedure carried on all four times.After the fourth time, they set the deficit limit to 2500 ml.The alarm sounded once 2500 ml was reached, and the device was zeroed out again and the procedure continued.The waste bag filled up.A non-hologic device was used to suction out the fluid.Six 3 l bags were used.They attempted to use this information to obtain a manual count.The final total deficit was 9,800 ml.The patient was brought to the icu following the procedure.She had interstitial swelling of the face and swelling of the tongue.She was released from the hospital a day after the procedure.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Common Device Name: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9153882
• Report Number: 1222780-2019-00231
• Device Sequence Number: 11436477
• Product Code: HIH
• UDI-Device Identifier: 15420045508552
• UDI-Public: (01)15420045508552(21)
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180825
• Number of Events Summarized: 1
• Summary Report (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): 09/13/2019

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: 09/13/2019
• Initial Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other