Cause of Device-Related Incident
External factors; Support system failures; User errors

Clinical Specialty or Hospital Department
Anesthesia; Clinical/Biomedical Engineering; CSR / Materials Management; Obstetrics and Gynecology; OR / Surgery

Device Factors
*Not stated

Document Type
Hazard Reports

External Factors
Medical gas and vacuum supplies

Mechanism of Injury or Death
Burn (electrical, thermal, chemical); Fire

Support System Failures
Failure to train and / or credential; Use of inappropriate devices

Tampering and/or Sabotage
*Not stated

User Errors
Abuse of device; Failure to read label; Improper connection

UMDNS
Medical Gas Cylinders [16-501]; Insufflators, Laparoscopic [16-849]

Use of Wrong Gas in Laparoscopic Insufflator Causes Fire



Hazard [Health Devices Jan-Feb 1994;23(1-2):55-6]

Problem

In preparation for laparoscopic surgery, a technician was directed to obtain a full "E" cylinder of carbon dioxide for the laparoscopic insufflator. From the storage area, the technician obtained a cylinder that was gray on top and green on its lower section and that had only part of a label that read "Carbon Dioxide." The technician connected the cylinder to the gas yoke of the insufflator, and the surgery proceeded.

Near the end of the procedure, the operative field rapidly became obscured by black smoke. After withdrawing the electrosurgical probe, the surgeon found that the probe's insulation had been burned away and that the trocar sheath had partially burned and melted. The patient most likely sustained severe burns to the internal abdominal wall and bowel, although the injuries have not been confirmed.

Discussion

A combination of errors contributed to this incident. The technician was not aware of the U.S. national standard color-coding scheme for marking medical gas cylinders (based on the Compressed Gas Association's [CGA] Pamphlet C-9, Standard Color Marking of Compressed Gas Containers Intended for Medical Use). For example, according to this standard, gray indicates carbon dioxide, green indicates oxygen, and a combination of colors indicates a mixture of gases designated with those colors. Relying only on the partial label, the technician thought he had obtained a carbon dioxide cylinder, but had actually obtained a cylinder containing a mixture of carbon dioxide and oxygen (as indicated by the two colors) in a 20:80 proportion, respectively.

The technician was able to install the incorrect cylinder in the insufflator's gas yoke because the indexing pins, designed to prevent connection of an incorrect gas cylinder, had been removed from the yoke. (Also see our Hazard Report, "Improper Connection of Laparoscopic Insufflators and Gas Cylinders," Health Devices 21[5], May 1992, for discussion of a similar problem.)

No one in the operating room recognized that the colors on the gas cylinder indicated that the wrong tank had been connected. Because of the 80% oxygen concentration in the pneumoperitoneum, either a small tissue ember or heat from the electrosurgical probe ignited the probe's insulation, causing the fire.

Recommendations

  1. Ensure that insufflator gas cylinder yokes are pin indexed to allow connection of only the proper insufflation gas, typically carbon dioxide (although nitrous oxide and helium are sometimes used and require gas-specific yokes). Routinely inspect the yokes (e.g., during scheduled inspection and preventive maintenance) for proper and intact indexing pins. Do not remove indexing pins, and do not purchase or accept delivery of yokes that have no pins. Label the insufflator with the type of gas with which it is to be used (e.g., "Insufflator Gas: Carbon Dioxide. Use gray tanks only.").
  2. Instruct operating room personnel and support technicians about medical gas cylinder color coding, and instruct them to check that the color of the insufflator cylinder indicates the gas intended for the procedure. In the United States, green indicates oxygen; gray, carbon dioxide; yellow, medical compressed air; blue, nitrous oxide; black, nitrogen; and brown, helium. (Other countries use color markings specified in the International Organization for Standardization's [ISO] Gas Cylinders for Medical Use—Marking for Identification of Contents [ISO 32].) Gas mixtures are indicated by two or more designated colors on the cylinder.
  3. Store gas cylinders in a manner that will minimize the risk of confusing gases (e.g., store special mixed gases separately).

UMDNS Terms

  • Medical Gas Cylinders [16-501]
  • Insufflators, Laparoscopic [16-849]

Cause of Device-Related Incident

User errors: Abuse of device; Failure to read label; Improper connection

External factor: Medical gas and vacuum supplies

Support system failures: Failure to train and/or credential; Use of inappropriate devices

Mechanism of Injury or Death

Burn (thermal); Fire


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