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

Model Number AQL-100PBS

Device Problems False Negative Result (1225); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

It is not possible to determine the most probable root cause based on the provided information.The device has not been returned for evaluation until now.There can be many reasons if the deficit indicated by the pump does not correspond to the expected deficit, including uterine perforation, nonreturn of irrigation fluid to the waste containers, so the system cannot calculate the deficit (e.G., fluid remaining on the floor, doctor's clothing or under-buttocks-drape; use of additional suction system with its own collection containers), wrong manual determination of the deficit or an actual malfunction of the device.However, it is not possible to exclude a malfunction of the device based on the provided information, therefore this event will be reported.

Event Description

We have been informed of the following notification of received hospital reports from health (b)(6): "aquilex machine bme1139 malfunctioned during procedure.Following cannister change aquilex machine showed negative deficit of -120 and seconds later showed negative deficit of -395 and quickly escalated to -450 mls of sodium chloride.Dr.Made aware at this time and an in and out fluid balance was done and determined at that time to be of no deficit.Rep for the aquilex machine was called at this time and was availa-ble only by phone.He was unable to determine why the machine was giving this negative deficit value.Procedure for fluid bag change and cannister change done as according to manufacturer's suggestion and as stated by equipment rep.During second cannister change the fluid balance quickly went to -50.High fluid loss alarmed at this time and the deficit went back down to -5 mls.During the case surgeon notified of fluid deficit by nurses in the room according to bags in and cannisters out.Notified at 500 mls, 800 mls, 1500 mls, 2100 mls, 2400 mls and final 2800 mls" additional information received: "(b)(6) 2022 tech support reached out to the customer j.P.Requesting additional information relating to the case.The customer responded with the following which is also attached: "here is what i can provide on behalf of the clinical team: i can comment that we were having significant issues with the aquilex not keeping an accurate reading of the fluid deficit and stop working, thus did a trial in mid-2020 for a new fluid management system; the thermedx and the fluent.We then purchased two thermedx management systems in (b)(6) 2020.I'm not sure how i could even begin to answer these very specific questions from two years ago to be honest but can answer broadly about our typical practice and hopefully that will help".Q1: which medical procedure has been conducted, e.G.Diagnostic or therapeutic? a1: we used the aquilex were for uterine distention for polypectomies, removal of fibroids and uterine septum repairs q2: what has been done, e.G.Uterine fibroid removal? a2: we used the aquilex were for uterine distention for polypectomies, removal of fibroids and uterine septum repairs q3: did perforation occur? if yes, was it confirmed using laparoscopy? a3: any time we think we have perforated we confirm with a laparoscopy typical-ly but unable to know for sure related to thebelow specifically q4: which pressure has been used? a4: the pressure we used and distension medium were pre set values hologic had placed on the generator q5: which distention medium has been used? a5: the pressure we used and distension medium were pre set values hologic had placed on the generator q6: which fluid bag size was used? a6: we would use 3000 ml size bags of both sorbitol mannitol(monopolar resectoscopes) and normal saline (myosure device lite, reach and xl) q7: which deficit value was displayed on the pump at the end of the proce-dure? a7: the aquilex was preset to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q8: which deficit limit had been set? a8: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9: has the deficit also been determined manually? a9: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9a: how much inflow fluid was used in total? a9a: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9b: how many fluid bags were used? a9b: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9c: how much fluid remained in the last opened bag? a9c: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when usingsorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done eachtime there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9d: how much fluid entered the container(s)? a9d: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbi-tol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suction-ing fluid off the floor at the end of the case q9e: how many containers had been removed during surgery? a9e: the aquilex was pre set to display a deficit of 1000ml, which is the max permit-ted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9f: how much fluid was inside those containers? a9f: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q9g: which deficit value has been determined manually? a9g: the aquilex was pre set to display a deficit of 1000ml, which is the max permitted when using sorbitol/mannitol.We would adjust the deficit limit to 2000ml when we were using saline.Manual calculation was done each time there was an issue to the best of the team's ability based on bags used, amount in cannisters and suctioning fluid off the floor at the end of the case q10:resetting to zero: has the pump been zeroed after priming/during the procedure? a10: the pump was always reset to zero after the line was primed to ensure accuracy q11: has fluid been left in the under-buttocks drape? a11: we always used a buttock fluid drape in all these cases, and if there was fluid in the drape at the end of the case, we would suck that up and manually calculate into the deficit q12: is fluid spilled on the floor? (if yes, approx.Volume) a12: q13: sn of the scale a13: patient/user impact no impact reported".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststrasse 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 15535228
• MDR Text Key: 306682294
• Report Number: 3002914049-2022-00010
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AQL-100PBS
• Device Catalogue Number: AQL-100PBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1