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

Model Number AQL-100PBS

Device Problem Insufficient Information (3190)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

The event was assessed by subject matter experts (among others by customer complaint management (ccm), medical affairs (ma), product management (pm), regulatory affairs (ra), person responsible for regulatory compliance (prrc), quality management representative (qmr)).The event description is very poor.The end user did not respond to further enquiries and did not return the device for evaluation.Also, preventive maintenance has been overdue since october 2022.However, we cannot rule out the possibility that the reported event may be related to the removal action (b)(4) 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.

Event Description

We have been informed of the following event: "the fluid deficit dropped from 1700 to 0 instantly without having collected that amount from the underbuttox drape as there was none present at that time.(b)(6) was present in the room and the scales had not been touched, a canister was not being changed and a saline bag was not being hung at that time.The physician ended the case with the last recorded deficit of 1700 and chose not to move forward.Patient status: no injury reported, no extended hospital stay or additional treatment needed.Additional information: tech support is confirming the system is functioning correctly".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL-100S
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SET
• 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 poststra?e 11; ludwigsstadt, 96337 ; GM 96337
• Manufacturer Contact: ellen giese ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 17414095
• MDR Text Key: 320484388
• Report Number: 3002914049-2023-00006
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/28/2023

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: 06/29/2023
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1