MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

There are two variants of the aquilex fluid control system have been cleared by fda (k112642 or k172040).As no serial number or ref numbers were provided by the complainant, it is unknown which variant is affected.The description of the complaint situation is very sparse, and the device was not returned to the manufacturer for evaluation until today.Further attempts will be made to obtain more information about the complaint situation, and to retrieve the device from the complainant.A follow-up report will be submitted.

Event Description

We have been informed of the following event: called at 9:17am to help troubleshoot regarding fluid deficit reading.Walked doctor and staff through the following suggestions: assess if there was possible perforation or leakage.Assess if any fluid has accumulated on the ground or if fluid has been collected underneath the drapes under the patient.Assess if there were any kinks or twists in the inflow tubing, where the tubing was spiked into the bag and where the tubing was wrapped around the pump.Asked if at any point did the fluid supply bag run dry? assess fluid amount from in's and out's (manual count).After manual count the team decided to abort the procedure.To my best knowledge, there is no known patient injury.

Manufacturer Narrative

There are two variants of the aquilex fluid control system have been cleared by fda (k112642 or k172040).As no serial number or ref numbers were provided by the complainant, it is unknown which variant is affected.No further information was provided by the complainant and the device was not returned.The manufacturer closed this case.

Event Description

We have been informed of the following event: "called at 9:17am to help troubleshoot regarding fluid deficit reading.Walked doctor and staff through the following suggestions: assess if there was possible perforation or leakage.Assess if any fluid has accumulated on the ground or if fluid has been collected underneath the drapes under the patient.Assess if there were any kinks or twists in the inflow tubing, where the tubing was spiked into the bag and where the tubing was wrapped around the pump.Asked if at any point did the fluid supply bag run dry? assess fluid amount from in's and out's (manual count).After manual count- the team decided to abort the procedure.To my best knowledge there is no known patient injury.":.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: HYSTEROSCOPY PUMP AND SCALE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 9822719
• MDR Text Key: 222066687
• Report Number: 3002914049-2020-00003
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1