Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Nursing; OR / Surgery

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Embolism (gaseous or particulate)

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Abuse of device; Device misassembly

UMDNS
Wound Drainage Kits [16-521]

Fatal Air Embolism from Misuse of Closed-Wound Suction Units



Hazard [Health Devices May-Jun 1990;19(5-6):200-2]

Problem

A member hospital reported a patient death from an air embolism associated with the use of a closed-wound suction unit. In several departments throughout the reporting hospital, users had difficulty draining thick secretions through the unit's inlet port antireflux valve, which prevents back flow of serosanguineous fluid and air. For this reason, in the reported case the user bypassed the antireflux valve by inserting a length of tubing connected to a stopcock through the valve. The drain plug in the outlet port, which allows air to be released while compressing the unit to create suction, inadvertently closed. Consequently, air was forced into the patient's chest, resulting in a fatal air embolism.

Discussion

The closed-wound suction unit is used to drain surgical wounds of serosanguineous fluid to prevent infections, hematomas, or other materials from accumulating and interfering with wound healing. Perforated tubing is inserted into the wound and connected to the evacuator container up to the indicator ring. The container maintains a near-constant medium-level vacuum, which causes the serosanguineous fluid to drain from the wound. Squeezing the pump bulb inflates a balloon and displaces air inside the container; air then flows through the open outlet port (drain plug out). As the balloon inflates, the antireflux valve prevents air from flowing into the patient. Following the evacuation of air from the container, closing the outlet port with the drain plug and the resultant slow release of air through the release valve in the pump bulb creates a vacuum in the container and drainage tube.

Two conditions led directly or contributed to air embolism in the reported case: 1) The antireflux valve was bypassed by the tubing, and 2) the drain plug was in the outlet port, closing it off. These improper practices caused air to flow into the patient when the clinician inflated the balloon.

The manufacturer was not aware that this type of wound-drainage system was being used for chest drainage, and other units are available for this application. Although the manufacturer does not specifically advise against this use, either on the unit or in its operator's manual, it does recommend against modifying the unit's setup. Also, the system's guidelines for selecting procedure-specific drain-and-closed-wound suction evacuators do not include chest-drainage procedures.

We believe that similar occurrences to the reported case are possible with any wound-drainage systems in which suction is created mechanically. However, the antireflux valve is built into the unit for patient safety. Disabling or bypassing this safety feature contravenes the manufacturer's instructions and not only defeats the function of the valve by preventing reflux of infectious material into the wound, but increases the risk of air embolism. If any modifications are necessary or the manufacturer's instructions are unclear, users should always contact the manufacturer for advice.

Recommendations

  1. Alert users that under no conditions should they bypass the antireflux valve on closed-wound suction units.
  2. Follow the manufacturer's directions carefully, and do not use a modified setup.
  3. Do no use closed-wound suction units for chest drainage unless they are specifically labeled for that use.

UMDNS Term

Wound Drainage Kits [16-521]

Cause of Device-Related Incident

Device factor: Design/labeling error

User errors: Abuse of device; Device misasssembly

Mechanism of Injury or Death

Embolism (gaseous)


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