Indian Society of Extracorporeal Technology

Indian Perfusionists


Safe Perfusion

Safety in clinical perfusion practice is the avoidance of unnecessary incidents that result in adverse patient outcomes. Its sphere of activity incorporates all issues relating to patient. It is critical for Perfusionists to make safety a top priority while implementing best practices to mitigate risks and improve safety procedures.

It is necessary to report perfusion safety related incidents and subsequently disseminate information to help provide a safe environment for the patients we treat. These incidents can lead to injury to the patient.

On these pages you will find incidents related to malfunctioning or defective equipment and supplies, Communication failure between healthcare team, Human error or incorrect execution of procedures and Failure to anticipate adverse events.

We would like to publish interesting reports to keep informed.

Heater Cooler Disinfection - Safety AdvisoryHeater Cooler Disinfection - Safety Advisory

The Swiss Agency for Therapeutic Products has published a safety notice written by the Federal Office of Public Health (FOPH) in Switzerland concerning a rare number of cases of water borne infection in cardiac surgery patients that have had implants. The effects of such a bacterial infection can take one or two years to develop in some cases. They have had 6 known cases between 2008 and 2012.

With regards to the cause of these infections the FOPH report states:

"The cause of the infection is suspected to be the contamination of a technical device (heater cooler unit) that is used in hospitals during open heart surgery to control the temperature of the blood. These devices are operated with filtered tap water. The bacterium was detected in the water and in the discharged air of the devices in several Swiss hospitals. It is possible that during very few of these operations, a transmission of the bacterium occurred. However, the exact route of transmission has not yet been established."

Whilst it is not conclusive that the heat-cooler is the cause of these infections the Safety Committee felt it helpful to remind the membership of the importance of following the manufacturers guidelines on disinfecting and cleaning their heater-coolers and ensuring the departmental protocols include these practices.

The recent circumstances and situation surrounding the potential Mycobacterial contamination of heater/cooler units and the possible but unconfirmed link to endocarditis and other surgical site infections.

Final guidance available to all parties concerned should be used by departments to develop a strategy plan. We recommend that all departments familiarise themselves will all the current guidance available via the links to the documents below and that you liaise closely with your local infection control team on this matter.

Attached is the link to the Sorin guidelines for the disinfecting and cleaning their heater-coolers.

Air Embolism - Safety Report

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.

  • 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 operating theatre.

  • Massive Air Embolism protocol review.

  • Introduction of 1 way valves to the vent suction line.

Communication within the theatre team should always be a priority.