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 Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

We have been informed of the following event: "information received by email on (b)(6) 2019 by area rep stating "we have an aquilex pump where the deficit has been off by over a 1000 and in the negatives.It failed the scale test and the fluid test.Can we have a new one shipped in to replace it? aql-100p - (b)(4), aql- 100cbs - (b)(4).".

Manufacturer Narrative

The device aql-100cbs with serial number (b)(6) is part of a recall that has been initiated at 2019-08-15.The fda was informed about the recall on 2019-08-29 (res 83712).The recall is performed, because a tilted, loose or missing bag deflector can lead to wrong deficit values.The deficit displayed by the device is lower than the actual deficit, which can lead to too much fluid entering the patient.The distributor hologic, inc.Informed the us end customers about the recall via written notification on september 5th with usps certified mail.The customer notification letter requests the users to perform both a visual (including testing whether the bag deflector is fixed properly) and a functional check of the device and only continue to use the device, if both tests have been passed successfully.It remains unknown whether the surgery team was aware of the information of the recall customer notification letter at the time of surgery.Hologic was informed about the event subject of this report on september 20th 2019.Wom submitted the initial report 3002914049-2019-00015 to fda on 18th october 2019.At that time, the device had not been returned to the manufacturer and a malfunction of the device could not be excluded.Wom received the device on 24th october 2019 and subsequently investigated the device function.Wom observed the following issues during visual inspection: the bag deflector is scratched and loose.The main scale pole is bent to the right side.The wheel base is scratched and wheels are corroded.At least the bent scale pole is a sign of forceful manipulation of the device due to customer misuse.A device with loose and bend components is defective and the labeling states: "warning! do not use this system if a defect is suspected or detected during the function check.This also applies to obvious defects, especially defects and damage to the power plug and power cord." during functional investigation, scale tests were out of tolerance and failed.This was to be expected due to the severe damage to the scale.The fluid deficit test was failed with the strict wom internal testing criteria, but passed in the less strict limits set out in the ifu.In conclusion, it can be summarized that an obviously defective device was used for the surgery.

Event Description

We have been informed of the following event: "information received by email on september 20, 2019 by area rep stating "we have an aquilex pump where the deficit has been off by over a 1000 and in the negatives.It failed the scale test and the fluid test.Can we have a new one shipped in to replace it? aql-100p - (b)(6); aql- 100cbs - (b)(6) ".

• 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: 9207579
• MDR Text Key: 217172990
• Report Number: 3002914049-2019-00015
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/06/2022

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-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1