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

Model Number FLT-100

Device Problem Use of Device Problem (1670)

Patient Problems Pulmonary Edema (2020); Hypervolemia (2664); Unspecified Kidney or Urinary Problem (4503)

Event Date 06/17/2021

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 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 and a definitive root cause for the reported event could not be determined.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.

Event Description

It was reported that on june 17th during a fluent procedure, the fluid deficit quickly augmented reaching a deficit of 2500 ml, the fluent console stopped the inflow and alerted the physician about reaching the limit for 2500 ml, then the physician decided to continue with the procedure by resetting the fluid deficit to zero.After the procedure, the patient was low on oxygen and presented with fluid in her lungs and blood in her urine which prompted the staff to admit her to the emergency room.No other information is available.

Manufacturer Narrative

Device was received, visual inspection was performed, and it was found that the tubbing for the device was cut, external evaluation showed no issues with the device, functional testing could not be performed due to the tubbing being cut.No other information is available.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.

• 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: 12124368
• MDR Text Key: 260252192
• Report Number: 1222780-2021-00157
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• 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: 12/02/2021
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2020
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Female