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
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.".
Additional Manufacturer Narrative
Model and type of product from aql-100 cbs to aql-100 pbs.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM AQL
• Common Device Name: 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
• Report Number: 3002914049-2022-00004
• Device Sequence Number: 2122807
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown