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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 Wound Dehiscence (1154); Fever (1858); Discharge (2225); Sweating (2444)
Event Date 07/29/2016
Event Type  Injury  
Event Description

Pt underwent emergent aortic valve replacement and hemi-arch repair with homograft on (b)(6) 2015 in setting of acute aortic dissection. Post-operatively had to return to operating room 3 add'l times, and then underwent final wound closure on (b)(6) 2015. In (b)(6) 2015, pt had focal superficial area of drainage and wound dehiscence - this was managed with local debridement and 2 weeks of antibiotics. In( b)(6) 2016, pt presented to (b)(6) hospital with fevers, night sweats, and pancytopenia. Ct chest performed that showed mediastinal collection. Pt taken to operating room (b)(6) 2016 found significant mediastinitis-tissue cultures growing candida and afb; subsequently identified as mac. Pt remains hospitalized at (b)(6) for management of this.

 
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Brand NameSORIN
Type of DeviceHEATER COOLER UNIT
Manufacturer (Section D)
SORIN
de
MDR Report Key5945792
MDR Text Key54560783
Report NumberMW5064676
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
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 HEALTH PROFESSIONAL
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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