Aquilex Fluid Control System (2019-08-14)

Starting date:

August 14, 2019

Posting date:

August 30, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70851

Last updated: 2019-09-05

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  Reason
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  Affected products

Affected Products

Aquilex Fluid Control System

Reason

W.O.M. has received complaints regarding incorrect fluid deficit measurements. If the displayed fluid deficit is lower than the actual deficit the patient could be overexposed to distention media. Exceeding the deficit limit can lead to a serious risks such as gynaecological tur syndrome (when using electrolyte-free solutions as irrigation medium) or pulmonary/cerebral edemas (when using electrolyte-containing solutions). This potential incorrect display of fluid deficit has been attributed to loose bag shields on the cart scale.

Affected products