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	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
We have been informed of the following event: "technical support was contacted by (b)(6) territory manager, to report hologic owned aquilex system is "the below aquilex pump/scale continue to show a negative deficit.There has been no reported adverse events, account has just been using pump and manually calculating the deficit." pump serial (b)(4) reported in (b)(4).Cart serial (b)(4) reported in (b)(4).Contact is (b)(6).Sr note 1: potential patient impact? no harm reported.".
Event or Problem Description
We have been informed of the following event: " technical support was contacted by rhonda myers territory manager, to report hologic owned aquilex system is "the below aquilex pump/scale continue to show a negative deficit.There has been no reported adverse events, account has just been using pump and man-ually calculating the deficit." pump serial (b)(6) reported in case (b)(4) tracking (b)(4) cart serial (b)(6) reported in case (b)(4) tracking (b)(4) contact is (b)(6).Sr note 1: potential patient impact? no harm reported".
Additional Manufacturer Narrative
The event was initially reported to fda on (b)(6)2019 (mfr# (b)(4)).Until today, neither the device nor further information could be obtained from the complainant.The case was closed.

• 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: 9178330
• Report Number: 3002914049-2019-00014
• Device Sequence Number: 2902299
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1