PERFUSION REPORTS

REPORT

021

DATE

TITLE

Paragon Oxygenator Heat Exchanger Leak

DETAILS OF INCIDENT

Within minutes of initiating bypass (paragon oxy), blood was observed to be entering the water lines of the heater cooler unit. Bypass was immediately suspended and a new circuit connected to the patient. Bypass was re-commenced and continued uneventfully, the failed unit was removed for investigation.

DETAILS OF INJURY TO PATIENT

No immediate injury observed. Blood gas parameters were within normal ranges and microbiology screens negative at reporting date.

TYPE OF DEVICE/MANUFACTURER

ACTION TAKEN

Local investigation, MHRA informed, supplier informed. The use of this device has been suspended pending outcome of the investigation.

RESPONSE FROM MANUFACTURER

N/A

ADDTIONAL INFORMATION

N/A

SUPPORTING VISUALS/VIDEO

N/A

SUPPORTING DOCUMENT

OTHER PERFUSION
REPORTS

Select and scroll to view chosen report

REPORT NO

123



5/7/24

Hardware Fault

REPORT NO

122



5/4/24

Oxygenator Failure

REPORT NO

121



8/3/24

Disposables: Eurosets Adult ECMO Oxygenator

REPORT NO

120



1/5/24

Disposable Incident

REPORT NO

119



Hardware: HCU Contamination

REPORT NO

118



12/9/23

Human Factors: ECMO Mobilisation

REPORT NO

117



27/9/23

Disposables: Oxygenator

REPORT NO

116



14/9/23

Disposable Issue: Reservoir in CPB circuit

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



1/11/21

Detached bullet tip of sump-updated response Sep 2022

Perfusion Report cards are shown in batches of 30 at any one time where available.

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