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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
Cannula
Device Brand Name:
OptiSite
Device Manufacturer's Name:
Edwards Lifesciences, LLC
Date of this Report:
(mm/dd/yyyy)
01/23/2015
Describe the Event
or Problem:
This device was inserted percutaneously into the pt's chest into the Aorta for ECMO circulation. Upon removing the surgical drapes and applying dressing there was noted to be a large amount of bleeding. There was over 2 liters of blood into the chest tube drainage Atrium. Doc ordered the pt to be re-prepped and draped to re-open pt for bleeding. Upon removing dressing and re-prepping the pt there was noted to be a pen-sized hole in this stated OptiSite arterial cannula. Doctor was called back and pt was re opened for mediastinal bleeding and he exchanged this cannula with a new 20 FR cannula.
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Manufacturer response for OptiSite Arterial Perfusion Cannula, Cannula (per site reporter)
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will replace.
the device(s) may have
caused or contributed to:
Potential for patient harm
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