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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. SORIN 3T HEATING COOLING UNIT 3T HCU

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SORIN GROUP USA, INC. SORIN 3T HEATING COOLING UNIT 3T HCU Back to Search Results
Model Number 3T
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Sepsis (2067)
Event Type  Injury  
Event Description

The patient underwent open heart surgery in 2014 x 2 (b)(6) during which time the sorin heater-cooler system was used. The patient was later identified/diagnosed with mycobacterium avium-intracellulare from blood, urine and bone marrow cultures obtained in (b)(6) 2016. We are unable to confirm the infection can be directly related to the use of the sorin heater-cooler system.

 
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Brand NameSORIN 3T HEATING COOLING UNIT
Type of Device3T HCU
Manufacturer (Section D)
SORIN GROUP USA, INC.
14401 west 65th way
arvada CO 80004
MDR Report Key5688281
MDR Text Key46257127
Report NumberMW5062526
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3T
Was Device Available For Evaluation? No Answer Provided
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/24/2016 Patient Sequence Number: 1
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