MAUDE Adverse Event Report: WORLD OF MEDICINE AQUILEX; FLUID CONTROL SYSTEM

Model Number AQL-100P

Device Problems Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/26/2015

Event Type  Injury  

Event Description

Pt scheduled for laparoscopic hysteroscopy with removal of uterine fibroid.Aquilex fluid management device was utilized to pump saline into the pt and provide increased distention of the surgical area to better visualize and remove the fibroid.Somewhere around 930-945 it was pointed out by circulator to surgeon that there was an approximate fluid deficit of 2000 cc normal saline.Staff later advised this was actually a 'guess'.Staff had apparently reset the fluid level readout on the aquillex several times during the procedure.Later analysis puts the estimated fluid deficit at around 4,000cc (7,000 cc administered, and only 3,000 cc recovered).The aquilex device has a "reset" button placed prominently on the front of the machine, which also acts to "silence" the alarm for maximum fluid deficient.This design too easily allows user to reset the fluid deficit level and thereby puts the pt at risk.

• Brand Name: AQUILEX
• Type of Device: FLUID CONTROL SYSTEM
• Manufacturer (Section D): WORLD OF MEDICINE; hologic MA 01752
• MDR Report Key: 4758572
• MDR Text Key: 5790861
• Report Number: MW5042557
• Device Sequence Number: 1
• Product Code: HIG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/05/2015

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?: Yes
• Device Operator: Other
• Device Model Number: AQL-100P
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 85