11 |
P a g e
Part Number - 00824 Revision K, DCO 2017-0074
© 2017 Thermedx
®
, LLC
o
Pulmonary Edema
o
Idiosyncratic Reaction (Intravascular coagulopathy, allergic reaction, including
anaphylaxis)
o
Rupture of a fallopian tube secondary to tubal obstruction
o
Cerebral Edema
o
Hypothermia: The use of room temperature distention fluids may contribute to
intraoperative hypothermia, which may consequentially increase the risk of acidemia
and cardiac arrhythmias, decrease myocardial contractility and interfere with
coagulation.
o
Tubal Spasms: The use of room temperature distention fluids may contribute to the
risk of tubal spasms, which may consequentially prevent placement of the tubal plugs.
o
Uterine Pain: The use of room temperature distention fluid may contribute to uterine
pain in diagnostic hysteroscopy procedures.
o
For additional guidance, see the 2013 AAGL Practice Report: Practice Guidelines for
the Management of Hysteroscopic Distending Media, and AORN Recommended
Practices for Minimally Invasive Surgery.
Bladder Distention
o
Monitor symptoms and signs of TUR Syndrome, including monitoring fluid deficit
levels, and identify factors that may increase its risk.
o
Increase in fluid irrigation flow rate may accelerate the normal 20 cc/min absorption
intravenously by the venous sinuses and may produce dilutional hyponatremia (TUR
syndrome of water overload).
Shoulder, Knee, and Small Joint Distention
o
Monitor and assess patient for signs and symptoms of potential arthroscopic
complications associated with fluid distention media for the particular procedure which
may include fluid extravasation, neuropraxia, compartment syndrome, vascular
injuries, and tachycardia, together with airway compromise, pneumothorax, and tissue
tearing particular to shoulder arthroscopy.
o
There is a risk of extra-articular edemas in patients with pathologically changed
articular capsules and for procedures involving an opening of the capsule (e.g., lateral
release).
o
Site swellings are complications which have been observed and described in the
literature in cases where roller pumps are used in arthroscopy. This build-up of fluid
can lead to post-operative swellings and pathological changes in patients. It is
therefore of the utmost importance that the surgeon monitors both the FluidSmart
®
and the patient closely during the procedure.
o
The use of overly warmed fluids above 43°C may increase the risk of thermal injury,
and/or damage to articular cartilage.
o
The use of room temperature arthroscopy irrigation fluids may contribute to
intraoperative hypothermia and/or articular cartilage damage.
o
The use of room temperature irrigation fluid for arthroscopy may contribute to
intraoperative hypothermia, which may increase blood loss, and/or contribute to
articular cartilage damage.
CAUTION
