MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM AQL-100S; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBESETS

Model Number AQL-100PBS

Device Problem Insufficient Information (3190)

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

Event Date 04/11/2023

Event Type  malfunction  

Event Description

We have been informed of the following event: "the deficit stopped recording half way through the procedure using xl myosure device.The customer hung a total of (16), 3l saline bags (total of 48,000mls) to remove a very large fibroid.The dr.Used 3-4 myosure xl devices.The customer had to use 16-17 canisters throughout the procedure.Troubleshooting: once deficit stopped on 0mls, the customer continued using the system but used manual count.The tm explained the customer suctioned about 400cc?s from the under buttocks drape.After the procedure customer pressed up and down arrows to show the amount of fluid used during the procedure and screen showed 0mls.Manual count by rep was 800mls but the dr.Recorded 200mls for deficit for there was a lot of fluid on the floor.Additional information apps spec explained there is a software anomaly with the aql-100pbs.Apps spec explained that once total fluid equals 30,000mls, the deficit will start to count backward to zero.It is recommended to perform a manual count going forward.Apps spec stated: ? be cognizant when you hang your tenth 3,000 liter bag? once the system fully depletes that tenth bag the inflow count will hit 30,000 which triggers the software anomaly (manually pause before you get there? system will not pause automatically, nor will it let you know) ? at that point write down your current deficit (before it starts counting backwards) and decide on how you want to proceed? abort when total inflow reaches 30,000 apps spec also stated too? reprime? write down where the deficit was at ? zero display and start process to reprime? set new deficit limit to be what was remaining from original deficit limit tm understood and thanked apps spec.No patient injury.Patient doing well, per tm.".

Manufacturer Narrative

At the time of the reporting decision the device has not yet been returned for evaluation and the evaluation results were not available.However, we cannot rule out the possibility that the reported event may be related to the removal action 8043980-(b)^) 2023-001-r that has already been performed.The most probable root cause is a software inherent threshold at ~ 30 l inflow volume, which was originally intended to prevent data bit overflow between the scale and control unit pump.Patient harm has not been reported.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL-100S
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBESETS
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; alte poststra[?]e 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: sushira panchama ; w.o.m. world of medicine gmbh; salzufer 8; berlin, berlin 10587 ; GM 10587
• MDR Report Key: 17736008
• MDR Text Key: 324126667
• Report Number: 3002914049-2023-00009
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2023

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: Health Professional
• Device Model Number: AQL-100PBS
• Device Catalogue Number: AQL-100PBS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female