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-100CBS

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Edema (2020)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

Patient suffered pulmonary edema.The end user did not respond to further enquiries and did not return the device for evaluation to date.However, it was mentioned that the indicated deficit of the pump showed an extremely higher value of 6000 ml compared to the manually determined value of only 600 ml.Therefore, the or staff was aware of an extremely high deficit and should have stopped the opera-tion earlier if the manual calculation was uncertain.Therefore, the most likely cause is an incorrect manual calculation.Recommended deficit limits for hypotonic and isotonic solutions: hypotonic solutions: electrolyte-free, hypotonic distention solutions are used when surgical equipment includes monopolar cutting tools.Traditionally, electrolyte-free hypotonic solutions containing a mixture of mannitol and sorbitol or glycine are used as distending media allowing for monopolar electrical systems to be used for coagulation and tissue resection.However, these low-viscosity fluids carry a substantial risk of rapid fluid absorption resulting in fluid overload, dilutional hyponatremia, and a variety of concomitant side effects.The latest aagl guideline provides recommendations for the use of the various distending media.The uterine cavity distension pressure should be the lowest pressure necessary to distend the uterine cavity and ideally should be maintained below the mean arterial pressure.For healthy patients, the maximum fluid deficit of 1,000 ml is suggested when using hypotonic solu-tions.Isotonic solutions: when bipolar electrical systems are included, isotonic distension fluids are used.The latest aagl guideline provides recommendations for the use of the various distending media.The uterine cavity distension pressure should be the lowest pressure necessary to distend the uterine cavity and ideally should be maintained below the mean arterial pressure.The aagl guideline published in 2000 advocated 2,500 ml as maximum limit for isotonic solutions.The bsge/esge (british and european society for gynaecological endoscopy, respectively) development group recommended a limit of 2500 ml in 2016.

Event Description

We have been informed of the following event: "tm states that the patient was going through a myosure/aquilex procedure and there was a fluid overload.Tm does not have info on which myosure device or sn for aquilex system.Tm states that the aquilex system had a deficit of 6000 but the manual count showed 600.Patient is being kept at the hospital due to pulminary edema.".

• 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: 17078090
• MDR Text Key: 316675061
• Report Number: 3002914049-2023-00004
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AQL-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 06/07/2023
• 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 Outcome(s): Required Intervention; Life Threatening