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
Additional Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of.Pump: aql-100p: 1601ce0401.Scale: aql-100cs: 1304ce415.A malfunction cannot be ruled out, because the complaint description states that tests have been performed by the territory manager and these tests failed.It remains unknown which tests have been performed and whether the deficit issues are serious enough to lead to a serious injury.Patient harm has not been reported.A follow-up report will be submitted after the device has been tested.
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 is having deficit issues.(b)(6) performed the testing and it failed.".
Additional Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of pump: aql-100p: (b)(6); scale: aql-100cs: (b)(6).The inital report was filed with fda on 13th december 2019 (mfr# 3002914049-2019-00018).At that time a malfunction could not be ruled out, because the complaint description states that tests have been performed by the territory manager and these tests failed.It still remains unknown which tests have been performed and whether the deficit issues have been serious enough to lead to a serious injury.Patient harm has not been reported.The complainant only returned the pump aql-100p, which was found to be working according to specifications.Until today, the scale aql-100cs has not been returned to the manufacturer.Therefore the case is closed.
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 is having deficit issues.(b)(6) performed the testing and it failed.".
Additional Manufacturer Narrative
Affected devices: aquilex fluid control system consisting of pump: aql-100p: 1601ce0401.Scale: aql-100cs: 1304ce415.The inital report was filed with fda on 13th december 2019 (mfr# 3002914049-2019-00018) and a first follow up report was filed with fda on 11th may 2020.Patient harm has not been reported.In the meantime we have been informed that the scale aql-100cs was returned and evaluated.The returned device shows several signs of forceful manipulation, which most likely caused mechanical and/ or electronic damages, leading to decalibration and thus to problems during deficit determination.The device also displayed an error with the scale connection.The scale was calibrated, deficit tests were repeated and passed.No further errors occurred.
Event or Problem Description
We have been informed of the following event: "technical support was contacted by eric koller territory manager, to report customer owned aquilex system is having deficit issues.Eric performed the testing and it failed.".

• 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: 9465315
• Report Number: 3002914049-2019-00018
• Device Sequence Number: 1965428
• 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,Followup
• Report Date (Section B): 05/25/2020

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: 04/16/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019; 11/13/2019
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 05/11/2020; 05/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1