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

Model Number	AQL-100CBS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to a revision in company procedures after a recent internal audit, this historical event was determined to be reportable.Recall information: recall reported to fda.Recall coordinator: (b)(6), pa-c; commander, u.S.Public health service.Res 83712.
Event or Problem Description
We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report customer owned aquilex system where he reports [after zeroing out the deficit would continually climb to 20ml without the inflow being on.It did this approximately four times before the case.During the case the deficit went negative from the beginning and continued to increase in the negative.Randomly and one point the deficit changed from negative to a positive deficit.The positive deficit was not in the vicinity of what the deficit actually was.] tech support requested the testing from the operators manual be performed on the site as it is normal for the machine to go into negative deficits but it should be accurate reading.Due to the variables that can throw it off we request the testing be performed.He will go to the site and see what results we get.(b)(6) tested the equipment per the operators manual with customer and it meets the output tests in section 8.No returns.2/6/2019 update - we had our first case today with the aquilex that was previously having problems but passed all the tests i performed it.All though it passed all tests we are still having big problems with the aquilex.The deficit is still jumping around by over large amounts without the machine being touched and not reading anywhere close to accurate deficits.Something is definitely wrong with this machine.Along with these problems it was also having suction problems and no amount of troubleshooting would fix it.] we will swap out the system.Pump serial (b)(4) will return in case (b)(4).Cart serial (b)(4) will return in case (b)(4).Contact is (b)(6).Replacement shipping to (b)(6).This will return on tracking number: (b)(4).".

• 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: 9074439
• Report Number: 3002914049-2019-00011
• Device Sequence Number: 2031193
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: AQL-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1