Health product recall

HysteroLux Fluid Management System (2020-11-23)

Starting date:
November 23, 2020
Posting date:
December 11, 2020
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-74521

Last updated:
2020-12-10

Affected Products

HysteroLux Fluid Management System

Reason

WOM has received complaints from customers in the United States that the display of inflow volume on the HysteroLux Fluid Management System can reach its limit of 32,450 mL during long procedures. In these cases, the display does not indicate the actual inflow volume. In cases where an unusually high amount of fluid is used for distension of the patient's uterus, the calculation of the inflow and outflow volumes reaches its limit and the pump control unit display will freeze at the maximum value. There is a risk of distension fluid reaching the circulatory system of the patient's soft tissue. Our investigation has identified a software anomaly as the cause for this display freeze. The reason for this is that at 32,450 mL an internal software calculation threshold is being reached. As the outflow measurement will continue, the result is that the deficit accumulated up to this point will start counting backwards until 0 mL is reached.

Affected products

HysteroLux Fluid Management System

Lot or serial number

All serial numbers.

Model or catalog number

72205000

Companies
Manufacturer

W.O.M. WORLD OF MEDICINE GmbH

SALZUFER 8

BERLIN

10587

GERMANY