Entry of Abdominal Fluids into Laparoscopic Insufflators
Hazard [Health Devices May 1992;21(5):181-2]
A member hospital reported an incident in which blood was delivered from
inside a laparoscopic insufflator to a patient. Bacterial cultures were taken to determine
whether the patient had been contaminated; the results were negative. Two days before this
incident, a long operative laparoscopic procedure had been performed using the same
insufflator. The hospital suspects that the CO2 E cylinder used for
insufflation was emptied during the earlier procedure; because the pressure at the patient
connector was lower than the abdominal pressure, blood from the patient's peritoneal
cavity was able to flow into the insufflator.
Although searches of the ECRI and U.S. Food and Drug Administration (FDA)
databases identified only one other report of blood inside a laparoscopic insufflator,
other member hospitals have informed us that their clinical engineering staffs have
discovered this problem on several occasions. In addition, several laparoscopic
insufflator manufacturers have reported to us that they have repaired insufflators (at a
cost of $500 to $1,600) whose pressure and flow sensors, solenoid valves, and pressure
regulators were damaged by entry of body fluids.
Laparoscopic insufflators are pressure-limited gas-flow regulators used to
produce a pneumoperitoneum. Several situations, such as insufflator deactivation, elevated
abdominal pressure, or an empty CO2 gas cylinder, can cause the pressure at the
insufflator's patient connector to be lower than it is in the patient's abdomen, allowing
fluid or gas from the abdomen to flow up the trocar cannula, through the insufflation
hose, and into the insufflator. Entry of body fluids or gases into the insufflator can
result in cross contamination or damage to the device.
Another potential source of contamination is the external gas cylinder.
Particulate matter (e.g., rust particles, dust, metal filings), which reportedly
originates in both reusable and disposable gas cylinders, can flow from the cylinder, into
the insufflation hose, and to the patient.
Passing medical gases through
a filter to protect the patient from contamination is a standard procedure
when using several medical devices (e.g., lasers, which use clearing and
cooling gases; anesthesia and respiratory therapy equipment). Several laparoscopic insufflator manufacturers
supply (or offer as an accessory) a disposable insufflation hose, which
connects the insufflator's patient connector to the insufflation needle or trocar cannula, with
a microporous in-line bacteria filter. In some cases, manufacturers may offer just a hose (without a
filter) or just a filter (without a hose). Most of the supplied filters are hydrophobic and have
a pore size of either 0.2 or 0.3 m . Using
a filter prevents the backflow of abdominal fluids into the insufflator and
precludes passage of almost all microorganisms as well as particulate matter.
The insufflator manufacturer should be able to supply a disposable,
hydrophobic, microporous in-line filter that can be positioned between the insufflator's
patient connector and the patient. If the manufacturer cannot provide a filter, hospitals
can contact other insufflator manufacturers who offer in-line filters (with or without the
disposable hose) that can be used with any laparoscopic insufflator. While some filters
that are purchased separately must be attached to the insufflator's patient connector and
are therefore not suitable for use with all insufflators, the hose-filter assembly kit
will typically be compatible with the insufflator.
- Ensure that all personnel involved with
laparoscopic surgery are aware of this report.
- Always have a second, full CO2 E cylinder available during each laparoscopic procedure.
Replace the primary cylinder before it is emptied when necessary (e.g., for
- During all laparoscopic procedures, use a disposable hydrophobic filter
between the insufflator's patient connector and the patient to protect the patient from
exposure to particulates originating in the external CO2 gas cylinder
and exposure to microorganisms contained in the abdominal fluids and gas in
a contaminated laparoscopic insufflator. The filter's microporous membrane
should be effective in retaining particles as small as 0.2 or 0.3 m . Obtain
written confirmation of the compatibility of the filter (and insufflation
hose) with the insufflator. (We have not assessed the differences in
performance, safety, and cost among the available filters.)
- Because improper filters can significantly reduce
flow, use only a filter that is compatible with the insufflator.
- On completing each laparoscopic procedure, disconnect the insufflation
hose from the trocar cannula before deactivating the insufflator.
- After each procedure, discard the filter; the
presence of fluids or contaminants on the patient side can result in cross
contamination and reduce the insufflator's delivered flow.
- Because no filter is 100% effective in retaining contaminants, use the
following measures to reduce the likelihood of patient contamination:
- Position the insufflator so that it is
elevated above the level of the patient's abdomen.
- Flush the insufflator and the insufflation hose with CO2 before creating the
pneumoperitoneum to remove any residual air and thereby reduce the
risk of air embolism. This procedure can also help to determine
whether residues were present inside the insufflator. If such
residues are found, use another unit for the procedure, and inspect
the contaminated unit to be sure it is in working order; if the unit
is damaged, return it to the manufacturer for repair.
- Ensure that abdominal pressure does not exceed the insufflator's
set pressure during a laparoscopic procedure. This will prevent
abdominal fluids and gas from flowing into the insufflation hose (as
well as eliminate the hazards associated with overpressurization of
the peritoneal cavity).
Insufflators, Laparoscopic [16-849]
Cause of Device-Related Incident
Device factor: Design/labeling error
User errors: Failure to perform pre-use
inspection; Inappropriate reliance on an automated feature
Mechanism of Injury or Death