Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; Obstetrics and Gynecology; OR / Surgery

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Infection

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Inappropriate reliance on an automated feature

UMDNS
Insufflators, Laparoscopic [16-849]

Entry of Abdominal Fluids into Laparoscopic Insufflators



Hazard [Health Devices May 1992;21(5):181-2]

Problem

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.

Discussion

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.

Recommendations

  1. Ensure that all personnel involved with laparoscopic surgery are aware of this report.
  2. 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 long procedures).
  3. 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.)
  4. Because improper filters can significantly reduce flow, use only a filter that is compatible with the insufflator.
  5. On completing each laparoscopic procedure, disconnect the insufflation hose from the trocar cannula before deactivating the insufflator.
  6. 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.
  7. 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).

UMDNS Term

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

Infection


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