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

Model Number AQL-100CS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Preliminary results per 27th of may 2019: according to the described event, the manual deficit was higher compared to deficit shown by the pump, then the pump showed the "scale overload" message.The returned scale was in poor cosmetic condition, both trays are bent, scale pole is bent, wheel base is scratched, and all 4 wheels are corroded.The "scale overload" message could be confirmed.Deficit calculation was out of specification but did not confirm described event (too high instead of too low as per complaint).The underlying cause of this event could be the damage to the device, also user error can not be excluded.

Event Description

We were notified of the following event: "(b)(6) contacted technical support (ts) (b)(6) 2019.She wanted to discuss an aquilex procedure.Ts successfully transferred the call to application specialist.Potential patient impact? no harm reported.Ts resolution: surgical applications specialist received a transferred call from gss technical support representative (b)(6).Hologic tm, (b)(6), called with a question regarding aquilex (b)(4) tm stated aquilex was used during a procedure.Tm stated at end of case "scale overload" message was displayed on pump.Tm stated front canister was full but there was no cords or any additional weight on canisters that could be observed.Tm stated deficit was also incorrect.Tm stated deficit on pump read 230 and manual deficit count was 1500.Surg apps asked if tm had serial number off of cart/scale.Tm denied.Surg apps stated serial number off scale would be needed to investigate.Surg apps stated surg apps would recommend hospital biomed department run checks located in ifu to ensure system was operating within specifications.Tm asked if surg apps could email ifu.Surg apps confirmed.Surg apps emailed tm ifu to forward to hospital biomed department.Tm will call back with serial numbers.Tm called back and stated biomed reported scale check was completed however scale overload message was displayed dur-ing testing.Tm provided serial number (b)(4) for scale and (b)(4) for pump.Surg apps stated cart/scale and pump would be investigated and tech support would get back with tm regarding next steps.Contact at account is (b)(6).".

• 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
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer Contact: soeren markworth ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 8657964
• MDR Text Key: 203897025
• Report Number: 3002914049-2019-00003
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702002145
• UDI-Public: 04056702002145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2019

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
• 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: 05/15/2019
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1