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

Model Number AQL-100CBS

Device Problems No Device Output (1435); Suction Problem (2170); Failure to Cut (2587)

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

Event Type  malfunction  

Event Description

We have been informed of the following event: "potential patient impact? no harm reported.Ts resolution: surgical applications specialist (apps spec) received an email to contact tm (b)(6) in re: to the procedure from (b)(6) this morning at 7:06 am pst.[case (b)(4) - suction issue, solved].Apps spec explained to (b)(6) that (b)(6) from (b)(6) called in to report an issue with the suction but that was resolved and then the customer hung up.[case (b)(4) - myosure issue, not aquilex related].(b)(6) stated it seems the dr.And staff ((b)(6)) had more issues after the initial call.(b)(6) stated this was a long-complicated procedure and during cutting a large 6cm fibroid the control unit shut stopped working the cutting ceased.[case (b)(4) - deficit issue, aquilex related].The 2nd issue while using the aquilex the deficit stayed around 1900 for some time but then jumped to 0 and stayed at -62.The customer used 12 canisters and from all the changing out and pausing of the system, all that jostling, may be the reason for the jumping around of the deficit on the pump screen.(b)(6) stated due to that the customer performed a manual count and ended up having more fluid coming out than what went in.They ended up calculating manually 3000ml more.The customer claimed to have looked everywhere for another bag but could not find where that additional 3000mls came from.There was no patient injury reported.Apps spec recommended the customer or tm perform the deficit test which can be found in the back of the ifu in order to make sure the system is in spec.This will also provide confidence that the system is functioning as intended and returns of the pump would not be necessary.[bubble issue - not aquilex related].The customer also mentioned to (b)(6) that at the end of the procedure it was noted that in one of the canisters the liquid/blood was bubbly and foamy.The customer nor tm had an answer for why this could be other than some outside influence because that does not seem to be aquilex related.Apps spec was not certain, but the cus-tomer should discuss with the dr.And have the dr.Use their medical judgment to explain what may have caused that.The tm understood and thanked apps spec for all the information.No patient injury reported.Procedure completed.No returns requested at this time.Customer satisfied.Call closed.".

Manufacturer Narrative

The event was initially filed with fda on 14th february 2020 (mfr# 3002914049-2020-00002).Until today, the device was not returned by the complainant for investigation by the manufacturer.Therefore, the case is closed.

Event Description

We have been informed of the following event: "potential patient impact? no harm reported.Ts resolution: surgical applications specialist (apps spec) received an email to contact tm hayley augustine in re: to the procedure from prisma health baptist this morning at 7:06ampst.[case (b)(4) deficit issue, aquilex related].The 2nd issue while using the aquilex the deficit stayed around 1900 for some time but then jumped to 0 and stayed at -62.The customer used 12 canisters and from all the changing out and pausing of the system, all that jostling, may be the reason for the jumping around of the deficit on the pump screen.Hayley stated due to that the customer performed a manual count and ended up having more fluid coming out than what went in.They ended up calculating manually 3000ml more.The customer claimed to have looked everywhere for another bag but could not find where that addi-tional 3000mls came from.There was no patient injury reported.Apps spec recommended the customer or tm perform the deficit test which can be found in the back of the ifu in order to make sure the system is in spec.This will also provide confidence that the system is functioning as intended and returns of the pump would not be necessary.".

• 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: 9710865
• MDR Text Key: 221030787
• Report Number: 3002914049-2020-00002
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (y/n): N
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AQL-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1