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

Model Number AQL-100CS

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2021

Event Type  malfunction  

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 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 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.".

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
• Type of Device: HYSTEROSCOPY PUMP AND SCALE,
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 11455538
• MDR Text Key: 245305746
• Report Number: 3002914049-2021-00001
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1