FSN REPORTS

FSN
008
DATE
1/9/2015
TITLE
Potential Mycobacterial Contamination Of HCUs
PROBLEM

Safety Advisory

The joint Perfusion bodies and their Safety Committee (SC) are fully aware of the recent circumstances and situation surrounding the potential Mycobacterial contamination of heater/cooler units and the possible but unconfirmed link to endocarditis and other surgical site infections.

We are working closely with the relevant organisations involved in this investigative process including Public Health England (PHE), NHS England, MHRA, DH, SCTS and ACTA. PHE is coordinating the national response. PHE are currently looking at de-escalating the issue with a timeline consistent according to the final round of testing on some of the latest devices. By de-escalation, PHE are referring to some final guidance that will be available to all parties concerned that should be used by departments to develop a strategy plan. We recommend that all departments familiarise themselves will all the current guidance available via the links to the documents below and that you liaise closely with your local infection control team on this matter.

Should you or your department wish to discuss this issue further or have any queries concerning these documents, the safety committee ( safetycommittee@scps.org.uk ) are willing to be of assistance, but we also need to remind you that the most up to date information will always be held by PHE.

OTHER FSN REPORTS

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REPORT NO
016
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Getinge HCU40 Replacment of Vacuum Valves
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015
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014
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013
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REPORT NO
012
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REPORT NO
011
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REPORT NO
010
1/4/2020
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REPORT NO
009
1/3/2017
Infections Associated With HCUs In CPB & ECMO
REPORT NO
008
1/9/2015
Potential Mycobacterial Contamination Of HCUs
REPORT NO
007
1/2/2014
SWISSMEDIC: Water-Borne Infection In Implant Patients
REPORT NO
006
1/1/2014
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REPORT NO
005
1/1/2012
Maquet Adhesive Failure On Oxygenator Blood Outlet Connector
REPORT NO
004
1/8/2011
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REPORT NO
003
1/6/2011
Maquet Transient Increase In Pump Speeds
REPORT NO
002
1/3/2011
Terumo CDI500 Possibility Of Parameter Drift
REPORT NO
001
1/2/2009
Datascope IABP Harness Not Fit For Purpose
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001
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