MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPY PUMP AND SCALE,

Model Number	AQL-100CS
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of pump: aql-100p: (b)(4).Scale: aql-100cs: (b)(4).Patient harm was not reported.In general, the description of the event is very poor.As no statement was made about the extent of the deficit problems and no queries were answered nor were the units sent in for examination, a malfunction that could fulfil the reporting criteria cannot be completely ruled out at present.Further attempts will be made to obtain more information about the complaint situation and to retrieve the units from the complainant.A follow-up report will be submitted.
Event or Problem Description
We have been informed of the following event: "(b)(6) in bio med reports staff was using aquilex pump serial number (b)(4) and cart serial number (b)(4) staff is reporting deficit was inaccurate.System is not due for a pm until (b)(6).She is going to run the annual testing and let us know the results.Rep ben summerhayes notified.Anna was going to re-run the testing and notify tech support if they need to get system replaced.".
Event or Problem Description
We have been informed of the following event: "anna in bio med reports staff was using aquilex pump serial number (b)(6) and cart serial number (b)(6) staff is reporting deficit was inaccurate.System is not due for a pm until (b)(6).She is going to run the annual testing and let us know the results.Rep ben summerhayes notified.Anna was going to re-run the testing and notify tech support if they need to get system replaced.".
Additional Manufacturer Narrative
The reported event could be not confirmed.There are no indications of a manufacturing issue.The returned device showed severe signs of mishandling, but the functional tests were passed.The complaint scenario could not be confirmed, and a malfunction was excluded.Additional reasons why the deficit displayed by the pump does not correspond to the expected deficit, include uterine perforation, non-return of irrigation fluid to the waste containers, so the system cannot calculate the deficit (e.G.Fluid remaining on the floor, doctor's clothing or under-buttocks-drape; use of additional suction system with its own collection containers), or wrong manual determination of the deficit.The most possible root cause is one of the aforementioned device-independent issues.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Common Device Name: HYSTEROSCOPY PUMP AND SCALE,
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 11455538
• Report Number: 3002914049-2021-00001
• Device Sequence Number: 17486311
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K112642
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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-100CS
• Device Catalogue Number: AQL-100CS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1