Safety InformationJaSECT Safety Committee (June, 2017)

What to do in case of Cardioplegia Delivery
System Failures
If the delivery system fails when delivering cardioplegic solution, depending on how you
respond, adequate myocardial protection may not be obtained, and myocardial injury may occur.
Following are some points to note and countermeasures when the cardioplegia delivery systemfails. Please refer to them to ensure safe and reliable delivering of cardioplegic solution. However,since each facility has different cardioplegia methods and delivery systems, there is a wide varietyof troubleshooting strategies, so please use this Safety Information to develop a plan of action foreach facility.

【Points to note in the initial action upon trouble】
1) If a problem occurs with the delivery system and cannot be restored, inform the surgeon
and anesthesiologist, and use an alternative delivery method, such as manual operation.
2) If delivering is difficult, it is necessary to check the allowable time before cardioplegiadelivery.
3) Even when delivering by alternative methods, the prescribed volume of cardioplegic solution
must be delivered, paying attention to the perfusion or the distal pressure.
4) In case of a system that delivers blood cardioplegia with two pumps or a chamber-type
delivery system, it would be difficult to deliver a precise mixing ratio by manual operation, so
it is necessary to consider alternative measures in advance.
5) The composition of cardioplegic solution upon trouble should be thoroughly discussed in advancewith the physicians.
Handling① If only the display is disabled:• The operation of the delivery pump should be checked visually and by perfusion or distalpressure.
• If the pump is operating, the delivery volume should be determined by the delivery time.
• Attempt to add monitors and reboot the device.
• If the display does not resume, please refer to the next section “If the entire system isdisabled” below.

② If the entire system is disabled:• Check the power supply status.
• If there is a spare system available, replace the system.
• If a spare system is not available and using only crystalloid cardioplegia, switch to amethod using gravity and pressurization bag for its delivery. If blood cardioplegia is used,
store a certain amount of blood from the heart-lung machine in an infusion bag, add theprescribed crystalloid solution and deliver the mixed solution using a separate pump.
• In case of a chamber type delivery system, check the manual provided by themanufacturer and deliver with the dedicated manual device. (If blood cardioplegia isused, a pre-mixed cardioplegia solution must be available for delivery.)• If the system cannot be restored and manual delivery is performed, careful attention isneeded as the bubble detector or level sensor is not available.

Countermeasures••••••

Prepare a blood bag to store a certain amount of blood from the heart-lung machine andmix it with the prescribed amount of crystalloid to deliver cardioplegia solution. A
separate circuit is required if delivery is to be done by another pump, so an emergency
circuit should always be available.
Be sure to know in advance the flow rate per revolution for manual operation in theroller pump or the chamber type system. (Flow rate is especially important for Calafiore
cardioplegia and microplegia.)
Since blood cardioplegic solution has electrolytes corrected to the appropriate ratio withblood, its composition should be considered in advance, assuming the case of switching
to delivery of crystalloid solution only.
If the system also incorporates a cooling system, there is a possibility of a cooling
shutdown, so a method to cool the crystalloid solution should also be considered.
If the perfusion or distal pressure is displayed on the cardioplegia delivery system, aspare monitor should be prepared in case of failure.
Simulation training for troubleshooting should be conducted on a regular basis to
respond promptly to problems with cardioplegia delivery system.