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	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the followind event: "part description: aql pbs serial number or, lot number of reported item: 1911ce1150 , date of procedure: (b)(6) 2022, date product support or hologic employee notified of issue reported: (b)(6) 2022, issue reported: customer called tm explaining that during a procedure, the deficit jumped from 2000mls down to 200mls.Tm stated the fluid deficit test passed after checking post op.The customer stated 19+ saline bags were used in the 2-hour procedure.The customer left all fluid bags on the hooks and did not lift any bags while replacing during procedure.The customer also claimed the deficit went negative at some point during the procedure.Troubleshooting performed: no information provided how did the procedure complete: despite the inaccuracies of the deficit, the procedure completed without injury.Patient status: no injury reported.Replacement requested: n.Letter of investigation requested: n.Is product returning for investigation: n.Site contact information: na.Additional information: apps spec confirmed manual count was 1500mls and pressure was set to 80mmhg throughout the procedure.The mean arterial pressure (map) is unknown.It is uncertain how the deficit would change from large amount to small amount to negative throughout procedure.Nothing was draped on the scales at any time.Case closed.Patient/user impact no impact reported".

• 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: 15189747
• Report Number: 3002914049-2022-00006
• Device Sequence Number: 5851894
• Product Code: HIG
• UDI-Device Identifier: 04056702006914
• UDI-Public: 04056702006914
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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