MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Model Number AQL-100P

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2018

Event Type  malfunction  

Event Description

During the procedure, the 3000ml bag of saline ran dry.I left the room the room to get more bags of saline.Upon returning to the room, i was informed that the deficit had increased 800ml and that 200ml were on the floor.I allowed for the 1000ml and informed doctor that when the deficit reached 3500ml on the fluid management system that we would have to stop.She agreed.Aquilex fluid management system (b)(4), myosure (b)(4) alarm went off at 2500ml.We stopped surgery at 3500ml.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; 4531 36th st; orlando FL 32811
• MDR Report Key: 7494122
• MDR Text Key: 107592068
• Report Number: 7494122
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: AQL-100P
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR