PERFUSION REPORTS

REPORT
011
DATE
1/1/2013
TITLE
LV Vent Placed In Raceway In Wrong Direction
DETAILS OF INCIDENT

On establishing cardiopulmonary bypass the surgical team became aware that air had entered the heart after noting the presence of an air bubble within the cardioplegia cannula. The visible air was cleared at the time and the operation continued.

Post-operatively, it became evident that the Patient had sustained a hypoxic brain injury. The cause was identified as a significant air embolism during the institution of bypass. It was later established that the LV vent had been configured such that it temporarily blew air into the left ventricle.

The patient did not regain consciousness post-operatively. Following repeated CT scanning and clinical reviews, the prognosis was felt to be extremely poor. Treatment was withdrawn and the patient died. The root causes were human error and equipment factors. Human factors were also contributory.

DETAILS OF INJURY TO PATIENT
TYPE OF DEVICE/MANUFACTURER
ACTION TAKEN
  • The equipment was checked and found to be functioning normally. Due to the design of the pumps, the risk of human error leading to an inadvertent change of flow direction to the vent pipe was real. This potential to inadvertently reverse the flow on the Sorin S3 pump has been demonstrated to all members of the perfusion team. This has increased vigilance and patient safety.
  • Once the heart-lung machine has been set-up and existing safety checks completed, it should be switched to zero revolutions rather than placed in standby mode. This should be added to the Perfusionists protocol checklist.
  • Fluid should be aspirated into the vent line prior to its insertion (wet table test). This is a task that should be incorporated into the normal checks undertaken by the scrub nurse.
  • Human factors were contributory to this incident. Investigating this incident has provided a further platform for improving communication and team working within the shared leadership environment of the operating theatre.
  • Massive Air Embolism protocol review.
  • Introduction of 1 way valves to the vent suction line.

The safety committee recognises the potential for human error and recommends all users of the S3 pump to raise awareness of the potential to inadvertently reverse the flow on these pumps. The wet table test of all suckers should be standard to avoid errors. Wet testing of vents prior to insertion will further increase the safety of these devices. The introduction of one way valves to the vent lines should be considered. Communication within the theatre team should always be a priority and without barriers.

RESPONSE FROM MANUFACTURER
ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

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