Cause of Device-Related Incident
Device factors; User errors

Clinical Specialty or Hospital Department
Anesthesia; Clinical/Biomedical Engineering; Nursing; Pulmonary / Respiratory Therapy

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Barotrauma; Suffocation

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
Accidental misconnections; Device misassembly; Failure to perform pre-use inspection; Improper connection

UMDNS
Breathing Circuit Adapters [10-123]; Breathing Circuits, Anesthesia [10-139]; Breathing Circuits, Ventilator [15003]

Rubber Universal Breathing-Circuit Adapters: Risk of Increased Disconnections



Hazard [Health Devices Nov 1991;20(11):444]

Problem

Breathing-circuit disconnections have resulted in patient injury and death. With the widespread use of standard conical fittings, which meet the current American Society of Testing and Materials (ASTM) Standard F1054-87, breathing-circuit disconnections and the hazards they cause have become rare; when they do occur, they are usually detected by alarms. Although conical fittings can be engaged tightly enough to resist disconnection from most normally encountered forces, some users continue to use soft rubber universal adapters (which stretch to fit different sizes and types of connectors) in patient circuits; these adapters do not meet the ASTM standard and are prone to disconnection.

Discussion

Most universal adapters can resist considerable axial force before disconnecting; however, they can be easily disconnected by even small off-axis forces. Also, unlike standard conical 15 and 22 mm fittings, it is possible to misassemble some other type of circuit into a breathing circuit when universal adapters are used.

Recommendations

  1. Discontinue using universal adapters or other soft rubber components in breathing circuits and other special circuits that are used with patients.
  2. Always use an exhaled-volume or a CO2 monitor to detect leaks and disconnections of breathing circuits.

UMDNS Terms

  • Breathing Circuit Adapters [10-123]
  • Breathing Circuits, Anesthesia [10-139]
  • Breathing Circuits, Ventilator [15003]

Cause of Device-Related Incident

Device factor: Design/labeling error

User errors: Accidental misconnections; Device misassembly; Failure to perform pre-use inpection; Improper connection

Mechanism of Injury or Death

Barotrauma; Suffocation


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