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

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

Device Factors
Improper maintenance, testing, repair, or lack or failure of incoming inspection; Manufacturing error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Barotrauma

Support System Failures
Lack or failure of incoming and pre-use inspections

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection

UMDNS
Oxygenators, T-Tube [17-925]

Disposable T-Tube Oxygenators: Do Not Use before Inspecting or Testing



Hazard [Health Devices Mar-Apr 1992;21(3-4):137]

Problem

A member hospital reported that a pediatric patient in the Postanesthesia Care Unit (PACU) suffered barotrauma and died after being connected to a T-tube oxygenator. She had been breathing spontaneously through her tracheal tube when the defective, preassembled oxygenator was removed from its wrapper and connected to provide supplemental oxygen. No one inspected the oxygenator or noticed that the reservoir tube, through which the excess oxygen and exhaled breaths normally exit, was occluded by a tightly fitting disk near its end (see figure). The disk was apparently left in the tube inadvertently during the manufacturing process; the manufacturer subsequently recalled the lot and found no other defective units.

The oxygenator had been connected to a wall oxygen outlet, with the flow control set to deliver 10 L/min. When connected to the tracheal tube adapter, oxygen was able to flow only into, and not out of, the patient's airway and lungs. The pressure rose to a dangerous level within a few seconds (up to 50 psi).

Discussion

As with all disposable anesthesia and respiratory care equipment, even a device as simple as an oxygenator warrants inspection or testing before use with a patient. ECRI databases have numerous reports of defects in disposable breathing devices and components that were undetected by the quality control sampling and testing methods typically performed by the manufacturers; many of these defects subsequently caused injury or death. Most of the reports describe occluded fittings, split hoses and connectors, and foreign bodies; some of the defects, such as splits, occurred during connection of a circuit.

Unlike anesthesia and ventilator breathing circuits that are fully tested as components of a complete system, T-tube oxygenators are stand-alone devices that can be used by nurses and others who typically do not inspect or test medical equipment. Manufacturers should perform appropriate quality control procedures to ensure that products received by the hospital are safe. In addition, the hospital should have its respiratory therapy or anesthesia department staff inspect or test disposable products in batches before use. Device packaging and individual wrappers should provide warning labels and simple inspection and test methods (for devices that are used alone and not tested as part of a larger system).

One simple method of pre-use inspection for complete or partial occlusion in T-tube oxygenators, such as the one in the reported incident, is to look through the open reservoir tube. Oxygenators that cannot be inspected by sighting (e.g., because of the presence of a valve) should be tested before use with 10 L/min oxygen flow and a pressure gauge connected to the patient port; the pressure should not exceed 5 cm H2O or (if appropriate) the pressure setting of an integral PEEP valve.

Recommendations

  1. If no pre-use inspection or test procedure is specified for the T-tube oxygenators used in your hospital, contact the manufacturer for recommendations. If the manufacturer does not have an inspection or test method available yet, use the procedures described above.
  2. Inform all users of these disposable devices to anticipate occasional defective units and to always inspect or test them before use with a patient.

For further information, see our Hazard Report "Pre-Use Inspection of Disposables"

UMDNS Term

Oxygenators, T-Tube [17-925]

Cause of Device-Related Incident

Device factors: Improper maintenance, testing, repair, or lack or failure of incoming inspection; Manufacturing error

User error: Failure to perform pre-use inspection

Support system failure: Lack or failure of incoming and pre-use inspections

Mechanism of Injury or Death

Barotrauma

 


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