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

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.

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.

RESPONSE FROM MANUFACTURER

see attached response

ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO
SUPPORTING DOCUMENT

OTHER PERFUSION
 REPORTS

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REPORT NO
120
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REPORT NO
119
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REPORT NO
118
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REPORT NO
117
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Disposables: Oxygenator
REPORT NO
116
14/9/23
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REPORT NO
115
13/9/23
Disposable Error
REPORT NO
114
13/7/23
Dispoables
REPORT NO
112
20/2/23
HLM Hardware Error: S5 HLM - Dual roller cardioplegia
REPORT NO
111
10/2/23
Human Factors
REPORT NO
110
31/1/23
DISPOSABLE FAULT
REPORT NO
109
19/1/23
Disposable issue
REPORT NO
108
3/1/23
Disposable issue: Oxygenator leak
REPORT NO
107
6/12/22
Hardware fault. Electronic gas Blender failure
REPORT NO
106
1/11/22
ECG Interference
REPORT NO
105
9/9/22
Issue with use of disposable
REPORT NO
104
13/6/22
Human Factors
REPORT NO
103
25/7/22
Human Factors
REPORT NO
102
7/7/22
Disposable issue
REPORT NO
101
6/4/21
Irregular blood flow/foreign looking substance in Oxygenator
REPORT NO
100
20/4/22
Gas Line Filter Fault
REPORT NO
099
20/4/22
Human Factors: BiVAD Error
REPORT NO
098
4/4/22
REPORT NO
097
19/3/22
Disposables Issue
REPORT NO
096
18/3/22
Bubbles Sensor Activation
REPORT NO
095
1/1/22
Protamine Administration
REPORT NO
094
1/11/21
Oxygenation failure upon commencement of CPB
REPORT NO
093
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Detached bullet tip of sump-updated response Sep 2022
REPORT NO
092
1/10/21
Vapourizer Issue
REPORT NO
091
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Oyxgenator Leak
REPORT NO
090
1/10/21
Breach of chemical cleaner
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