PERFUSION REPORTS

REPORT

075

DATE

1/3/2021

TITLE

Electromagnetic interference with HLM

DETAILS OF INCIDENT

During an AVR with the cross clamp in situ a series of faults were noted on the S5 HLM. These included:

Temporary failure of the 3 sucker roller pumps: "Sucker pump 3 fault" was displayed on the control panel-causing all 3 sucker roller pumps to reset. The screens turned off and rebooted. Once they rebooted they were fully functional again. This fault occurred twice during CPB.

Failure of cardioplegia calculator on data panel. "Cardioplegia pump 4a fault" was displayed on the control panel. The blood volume was not recorded on the cardioplegia data panel. We administered a 4:1 cardioplegia dose but had to calculate the cardioplegia volumes manually.

Defective arterial clamp: Following CPB, an error was displayed on the control panel

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DETAILS OF INJURY TO PATIENT

There was no harm to the patient

TYPE OF DEVICE/MANUFACTURER

Liva Nova S5 HLM

ACTION TAKEN

The Liva Nova engineer was notified, they inspected the HLM machine and exported the data to send to the manufacturer. Initially the unit involved was not satisfied with the report genterated from Liva Nova (see below and attached) so waited for further instruction.

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After receiving the report from Liva Nova, further actions were taken:

Ferrite blocks were put on the display/control panel, the CP5 centrifugal console and the arterial clamp. There were already ferrite blocks on the electronic gas blender of the machine affected.

The other S5 machines in the unit had ferrite blocks put on the display/control panel. There were already ferrite blocks on the electronic gas blenders.

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RESPONSE FROM MANUFACTURER

see attached response

ADDTIONAL INFORMATION

SUPPORTING VISUALS/VIDEO

SUPPORTING DOCUMENT

Liva Nova Report