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

Model Number AQL-100CBS

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 on 2019-08-29.Recall coordinator: (b)(4).

Event Description

We have been informed of the following event: "technical support was contacted by (b)(6), territory manager, to report hologic owned aquilex system.Hospital staff called (b)(6) reporting the deficit not registering and then shooting to very large negative deficits during a case.She went and was present for the next case.They primed the system the numbers on the deficit reading never changed from 0 even though i had them run over 300ml of fluid into the underbutt drape.They switched systems after that to successfully complete the case.Tech support asked for confirmation that fluid hung on the supply hooks; confirm that nothing besides fluid bags are being hung on the supply hooks.Even when not in use, nothing (including the power cords) should be hung on them as its sensitive as it's a scale; confirm there is nothing besides canister rings on the scale at the bottom; confirm the pink shipping rubber tubes were removed from the white canister ring holder area.We do advise that we swap out both pieces.Pump serial (b)(4) reported in case (b)(4).Cart serial (b)(4) reported in case (b)(4).Contact at facility is (b)(6).(b)(4) noted nothing except fluid was on the hooks; nothing but canisters on bottom; yes.Pink plastic removed.Potential patient impact? no harm reported.Ts resolution: replacements shipping to (b)(6).This will return on fedex tracking number: (b)(4).".

• 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; alte poststrasse 11; 96337 ; GM 96337
• Manufacturer Contact: lucia puettmann ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 9074436
• MDR Text Key: 203896595
• Report Number: 3002914049-2019-00010
• Device Sequence Number: 1
• Product Code: HIG
• UDI-Device Identifier: 04056702006556
• UDI-Public: 04056702006556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/16/2019

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-100CBS
• Device Catalogue Number: AQL-100CBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1