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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
controller, temperature, cardiopulmonary bypass
Device Brand Name:
STOCKERT 3T
Device Manufacturer's Name:
Sorin Group USA, Inc.
Date of this Report:
(mm/dd/yyyy)
03/09/2016
Describe the Event
or Problem:
The patient underwent CABG x 3 approximately 28 months ago. Sorin Heater/cooler was used during the procedure. Subsequent information released by the company indicates potential risk for developing post operative infections related to airborne transmission of acid-fast bacilli (AFB). This patient was admitted to the hospital approximately 2 months ago for sepsis. Purulent drainage noted from prior sternal incision site. Culture positive for AFB. Wound required debridement and VAC dressing placement.
the device(s) may have
caused or contributed to:
Serious injury
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