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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN HEATER COOLER UNIT

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SORIN SORIN HEATER COOLER UNIT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Fever (1858); Granuloma (1876); Inflammation (1932)
Event Date 06/24/2016
Event Type  Injury  
Event Description
Patient underwent ascending aortic root/hemiaiarch reconstruction with aortic valve repair in (b)(6) 2015. A sorin heater cooler unit was used while this patient was on bypass. In (b)(6) 2016, he developed fevers of unknown origin, along with splenomegaly. This progressed to interstitial nephritis. Noted some hilar adenopathy on ct chest. Went to bone marrow biopsy for fuo work-up (b)(6). Granulomas were seen on biopsy and diagnosis of possible sarcoidosis was made initially. This culture came back positive for mycobacterium avium complex.
 
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Brand NameSORIN HEATER COOLER UNIT
Type of DeviceHEATER COOLER UNIT
Manufacturer (Section D)
SORIN
DE
MDR Report Key5945978
MDR Text Key54630053
Report NumberMW5064690
Device Sequence Number1
Product Code DWC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 09/07/2016 Patient Sequence Number: 1
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