PERFUSION REPORTS

REPORT
086
DATE
1/7/2021
TITLE
Electronic Gas Blender Fault
DETAILS OF INCIDENT

Routine CABG. Set up for case, all checks completed and satisfactory.

Harvesting of left radial artery and LIMA, so lines are not connected to the patient yet.

1045-Heparin given upon completion of left radial harvest.

1047-Connected lines up to the operating table.

1050-Checked gas flow through CDI, checked suckers and ACT reached 512

1050-1116-Connected to patient, gas flow set to 2.5 (this was enabled with no issues), RAP of arterial and venous lines.

1116-1117-Commenced CPB

1117-1122-Initial sight of arterial blood is red

Observation of venous and arterial blood darkening. Checked CDI and pO2 starting to drop. Perfusionist instructed nursing assistant to bring in another perfusionist. Perfusionist increases gas flow, no changes, no alarm from EGB.

Instructed anaesthetist to keep the lungs on. During this time tug tests of the gas line, no issues. Checked green gas line from EGB to oxygenator (including oxygen sensor); all in tact and no air leaks. Another perfusionist enters theatre and connects oxygen from a tank to the oxygenator and another perfusionist brings in a Sechrist gas blender.

Terminated CPB and transfused volume to the patient, patient stable.

1124-Perfusionist recommences CPB with the Sechrist gas blender. Case continues with no further problems and the patient is fine.

Post-CPB we connected the original EGB to the HLM and an error appears on the HLM "module/sensor defective". This had not occurred when the HLM was first turned on.

DETAILS OF INJURY TO PATIENT

None

TYPE OF DEVICE/MANUFACTURER

Liva Nova S5 Electronic Gas Blender

ACTION TAKEN

The faulty EGB was removed from circulation and the engineer from Liva Nova was informed. A datix was completed and all appropriate parties informed e.g. clinical technology. The Liva Nova rep subsequently sent the unit back to Germany for investigation.

RESPONSE FROM MANUFACTURER

Notes, Observations and Remarks:

EGB disinfected, opened, cleaned and checked.

Error confirmed, see report XXX

During pre-calibration error E1 was detected on O2.

Following parts were replaced, see items list.

Calibration was performed----OK

TSI and test run were performed----OK

ADDTIONAL INFORMATION
SUPPORTING VISUALS/VIDEO

See attached

SUPPORTING DOCUMENT

OTHER PERFUSION
 REPORTS

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REPORT NO
059
1/5/20
Failure to remove CO2 effectively
REPORT NO
058
1/7/20
Centrifugal Head Issue 3
REPORT NO
057
1/6/20
Centrifugal Head Issue 2
REPORT NO
056
1/1/20
Centrifugal Head Issue
REPORT NO
055
1/2/20
Faulty Pressure Relief Valves
REPORT NO
054
1/4/20
Leaking ALF
REPORT NO
053
1/2/20
Arterial Line Filter Leak
REPORT NO
052
1/3/19
Gas Line Filter Issue
REPORT NO
051
1/12/19
Dual Lumen Cannula Movement
REPORT NO
050
1/10/19
Venous Cannula Damaged
REPORT NO
049
1/12/19
Oxygenation Issue
REPORT NO
048
1/8/19
Roller Pump Failure
REPORT NO
047
1/12/19
Broken Cannula Dilator
REPORT NO
046
6/12/19
Gas Blender Error
REPORT NO
045
20/11/19
Tubing Detachments
REPORT NO
044
27/11/19
Interruption to IABP counterpulsation
REPORT NO
043
1/7/19
Getinge Mal-Position Of IABP Catheter
REPORT NO
042
1/2/19
Avalon Dual Lumen Cannula Crack
REPORT NO
041
1/2/19
Custodial Rubber Fragmentation In Spiked Bag
REPORT NO
040
1/10/18
Reservoir Clot
REPORT NO
039
1/10/18
Pall Clot In Cardioplegia Circuit
REPORT NO
038
1/10/18
Maquet HL20 Cardioplegia Pump Error
REPORT NO
037
1/10/17
Temed D200 Haemoconcentrator Clot
REPORT NO
036
1/10/17
Oxygenator issue
REPORT NO
035
1/10/17
Medtronic Fusion Oxygenator Blood To Gas Leak
REPORT NO
034
Possible Medtronic Fusion Oxygenator Failure
REPORT NO
033
Fannin Heparin Ampules Shattering
REPORT NO
032
Sucker Placed In Raceway In Wrong Direction
REPORT NO
031
High Transmembrane Pressure Gradients
REPORT NO
030
Faulty Connector On ECMO Soft Shell Reservoir Bag
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