Important Safety Alerts

Medical device manufacturer, W.O.M. World of Medicine GmbH, has issued a medical device safety alert concerning its Aquilex Fluid Management Pump [Part Number: AQL-100P and AQL-100PBS; All Serial Numbers].

According to the manufacturer, it received several complaints about deficit issues in the past and had observed that Aquilex Fluid Management Systems were used even though the system was mechanically damaged, or the deficit function was out of specification due to overdue preventive maintenance of the device. Failure investigation performed on complaint units indicates that the function test that is stipulated in the Instructions for Use (IFU) is not always performed. The IFU stipulates that a function test must be performed before the system is used to detect a malfunction of the device at an early stage.

The manufacturer states that, in case of some malfunctions, the deficit displayed by the pump can differ from the real deficit, leading to the following risks:

Worst case scenario:

• Displayed deficit too high
  • If the device displays a higher deficit than is currently present, at worst the surgeon might abort surgery too early and initiate additional surgery.
• Displayed deficit too low
  • If the device displays a lower deficit than is currently present, and the surgeon does not recognize (in time) the hazardous situation for patient, two scenarios are possible depending on the used irrigation fluid:
    • electrolyte-free solutions: the ion concentration (e.g. Na+) in the blood drops, which can lead to gynecological TUR syndrome at worst
    • electrolyte-containing solution: fluid overload can occur, which can lead to pulmonary and/or cerebral edemas at worst

The manufacturer will perform a product field action to add a 1000 g weight to the packaging of the pump and add the new labelling during biannually preventive maintenance. After preventive maintenance, an information letter is enclosed with the device which explains the changes to labelling and the execution of the function test.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 7 Jun 2021