MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM AQL-100; AQL-100CS

Model Number AQL-100CS

Device Problems Inadequate User Interface (2958); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Manufacturer Narrative

Patient harm has not been reported.As the device was not returned for evaluation and the end user did not respond to further enquiries, a malfunction cannot be excluded.

Event Description

We have been informed of the following event: "surgical applications specialist received a call from customer, requesting assistance with aquilex after a myosure procedure.Customer stated procedure is now complete and there is 2l unaccounted for and customer is unsure of what happened.Customer stated there is no fluid on the floor, or drape.All fluid has been returned to canisters.Customer stated 2, 3l bags were hung.Surg apps asked for deficit on aquliex display.Customer stated deficit showed 395 but it has been zeroed earlier because it was dinging.Surg apps asked for deficit when it was zeroed.Customer stated previous deficit was 1200.Surg apps stated 1200 plus 395 is 1595 which is not far off from 2l deficit mentioned.Surg apps asked for manual count.Surg apps asked how many bags were used and if there was any saline left in them.Customer stated there were 2 3l hung and there was about 500 left in each one.Surg apps asked for total fluid in all 4 canisters.Customer stated there was about 2700 total on all canisters.Surg apps stated information provided would equal a manual count of approximately 2300.Surg apps stated based on information being provided customer should assume there is somewhere between 2300 and 1595 deficit.Customer stated customer has just not ever seen such a high deficit in previous cases.Surg apps what pathology was being removed, pressure setting and length of case.Customer stated tissue was a fibroid and procedure lasted 30 to 45 minutes with pressure of 80.Surg apps stated every case is individualized but fibroids and lengthy cases can result in more fluid absorption that a quick polyp removal.Surg apps stated aagl guidelines state that 2500 cc is max deficit for saline in a young, otherwise healthy patient.Surg apps stated it is up to the doctor to determine what the max allowable deficit is for the patient on the table since only doctor knows the patient#s complete h & p.Surg apps stated as long as doctor understands that the saline has most likely been absorbed into the patient and it is not an error in calculation, they will know how to best manage the patient post operatively.Surg apps asked if customer had any more questions or concerns.Customer denied.Surg apps shared, for future reference, surg apps would not recommend zeroing deficit once procedure has begun.Surg apps stated the point of having a fluid management system is to have a running deficit for patient safety.Customer understood.Customer thanked surg apps and hung up.No patient injury reported.Surg apps called tm, josh and made tm aware of call so that tm may follow-up with account.No returns.Call closed.Patient/user impact no impact reported!".

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL-100
• Type of Device: AQL-100CS
• 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: 14047837
• MDR Text Key: 298503311
• Report Number: 3002914049-2022-00001
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2022

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-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/07/2022
• 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