MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM AQL; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS

Model Number AQL-100PBS

Device Problem Application Program Problem (2880)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

We have been informed of the following event: "nick m., clinical account manager, reports that during an aquilex trial procedure, the deficit reached about 2000ml at which point it began to reduce steadily down to 0.Unknown if procedure was completed.Nick performed scale test on system and deficit test, which both passed.Nick and his tm are´ requesting to have the aquilex replaced as this is the beginning of a trial.Rep was present.No patient impact reported.Awareness/procedure date (b)(6) 2022 update 5/18/22: applications specialist (apps spec) received a call from (b)(6), on (b)(6) 2022 @ 12:40pm pst.Brandon asked apps spec to assist with a report of an inaccurate deficit during an aquilex pbs procedure that occurred today.Brandon provided the cam#s info to call and discuss.Apps spec received a call from nick.Apps spec confirmed the initial deficit was 2000mls midway through the procedure however there was no fluid pooling in the under buttocks drape (ubd), on the floor or under the patient.Fluid would flow in and suction out without incident.No pausing or stopping of the system occurred.Nick explained that the dr.Was removing a very large fibroid and there was a lot of fluid leaking from the cervix however the fluid did not gather or pool in the ubd to attribute to the 2000ml deficit.Apps spec confirmed the fluid going in was suctioning out and systemnever stopped.Nick stated the deficit never should have been at 2000mls to start with.Then several minutes after the pump reached 2000mls, the deficit slowly began decreasing and finally reached 0mls.Nick stated that was inaccurate because a manual count ended up being around 750mls.The pump was tested, and everything checked out, but it is still concerning.Apps spec confirmed nothing was draped over the canisters or scales.Apps spec confirmed the pump head rotated fluid throughout the procedure without issue and without the bag running dry.No patient injury.Gss ts to process pump return for investigation.Pump - 2111ce0550 - 01061417 cart - 2111ce0773." "patient/user impact no impact reported.".

Event Description

We have been informed of the following event: "nick m., clinical account manager, reports that during an aquilex trial procedure, the deficit reached about 2000ml at which point it began to reduce steadily down to 0.Unknown if procedure was completed.Nick performed scale test on system and deficit test, which both passed.Nick and his tm are´ requesting to have the aquilex replaced as this is the beginning of a trial.Rep was present.No patient impact reported.Awareness/procedure date 5/18/22 update 5/18/22: applications specialist (apps spec) received a call from gss tech support rep, brandon, on 5/18/22 @ 12:40pm pst.Brandon asked apps spec to assist with a report of an inaccurate deficit during an aquilex pbs procedure that occurred today.Brandon provided the cam#s info to call and discuss.Apps spec received a call from nick.Apps spec confirmed the initial deficit was 2000mls midway through the procedure however there was no fluid pooling in the under buttocks drape (ubd), on the floor or under the patient.Fluid would flow in and suction out without incident.No pausing or stopping of the system occurred.Nick explained that the dr.Was removing a very large fibroid and there was a lot of fluid leaking from the cervix however the fluid did not gather or pool in the ubd to attribute to the 2000ml deficit.Apps spec confirmed the fluid going in was suctioning out and systemnever stopped.Nick stated the deficit never should have been at 2000mls to start with.Then several minutes after the pump reached 2000mls, the deficit slowly began decreasing and finally reached 0mls.Nick stated that was inaccurate because a manual count ended up being around 750mls.The pump was tested, and everything checked out, but it is still concerning.Apps spec confirmed nothing was draped over the canisters or scales.Apps spec confirmed the pump head rotated fluid throughout the procedure without issue and without the bag running dry.No patient injury.Gss ts to process pump return for investigation.Pump - 2111ce0550 - 01061417 cart - 2111ce0773." "patient/user impact: no impact reported.".

Manufacturer Narrative

Model and type of product from aql-100 cbs to aql-100 pbs.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL
• Type of Device: HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM AND TUBE SETS
• 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: 14731138
• MDR Text Key: 294267961
• Report Number: 3002914049-2022-00004
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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-100PBS
• Device Catalogue Number: AQL-100PBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1