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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP SORIN HEART LUNG MACHINE

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SORIN GROUP SORIN HEART LUNG MACHINE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)
Event Date 03/11/2016
Event Type  Injury  
Event Description
Infection control identified a case of mycobacterium chimera surgical wound infection today in a patient who underwent aortic valve replacement with bovine valve, cabg x 2, and implantation of a heartmate ii vad on (b)(6) 2015 at (b)(6) (as destination therapy). Patient has been intermittently hospitalized since (b)(6) 2016 with wound dehiscence and wound infection with mycobacterium avium complex. Later this isolate was identified as (b)(6) in our lab. Heater cooler bypass machine was used for this index surgery.
 
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Brand NameSORIN
Type of DeviceHEART LUNG MACHINE
Manufacturer (Section D)
SORIN GROUP
MDR Report Key5895844
MDR Text Key52867198
Report NumberMW5064231
Device Sequence Number1
Product Code DTQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/18/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2016 Patient Sequence Number: 1
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