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-100CBS
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: "brief description: deficit readings going to negative.Problem description: reporter: (b)(6).Part description: aquilex scale.Serial number or lot number of reported item: (b)(4).Date product support or hologic employee notified of issue reported: (b)(6) 2022.Issue reported: deficit readings going to negative.Replacement requested: yes.Is product returning for investigation: yes.Additional procedure information: technical support was contacted by (b)(6) who reported that the customer just received this system last month and are hav-ing issues where the deficit reading will go to negative reading randomly.A replacement is requested for the customer.A replacement system is being sent attn -pr.(b)(4).Patient/user impact: no impact reported".
Additional Manufacturer Narrative
The returned device was confirmed to be an aquilex pump s/n (b)(6), aquilex scale s/n (b)(6).The devices ran their self-check successfully.The pump had the latest software: 0.5.0.8.Incoming pressure and vacuum tests were performed, and both were within tolerance.A scale test was performed, with all results passed.Fluid deficit testing was conducted with the un-calibrated pump and scale, with all results passed.This complaint was not confirmed.The deficit test was within tolerance.The scale is working per specification.Device history for the reported device did not indicate any abnormalities and meets all specifications.
Event or Problem Description
We have been informed of the following event: "brief description deficit readings going to negative problem description reporter: jd - territory manager part description: aquilex scale serial number or lot number of reported item: (b)(6) date product support or hologic employee notified of issue reported: 11/28//22 issue reported: deficit readings going to negative replacement requested: yes is product returning for investigation: yes additional procedure information: technical support was contacted by jd - territory manager who reported that the customer just received this system last month and are hav-ing issues where the deficit reading will go to negative reading randomly.A replacement is requested for the customer.A replacement system is being sent attn -pr.Pump - (b)(6) case (b)(4) scale - (b)(6) case (b)(4) 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: 15995176
• Report Number: 3002914049-2022-00012
• Device Sequence Number: 5950037
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown