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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVA NOVA PLC SORIN STOCKERT 3T HEATER-COOLER UNIT DEVICE SORIN HEATER COOLER DEVICE

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LIVA NOVA PLC SORIN STOCKERT 3T HEATER-COOLER UNIT DEVICE SORIN HEATER COOLER DEVICE Back to Search Results
Model Number SEE PAGE 3.
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Fever (1858); Hematoma (1884)
Event Date 08/31/2017
Event Type  Injury  
Event Description

On (b)(6) 2016, patient underwent thoracic aortic dissection repair - bentall procedure. Sorin heater-cooler unit device was used during the procedure. No post-operative complications noted and patient was discharged on post-operative day 11. On (b)(6) 2017, patient admitted to hospital with fever of unknown origin. On (b)(6) 2017, patient underwent a mediastinal exploration and drainage of what appeared to be an old hematoma. Cultures obtained during surgery were positive for afb and results for isolate specification was positive for mycobacterium chimaera (results rcvd. 08/31/2017). On (b)(6) 2016, thoracic aortic dissection was repaired using a 25mm st. Jude valved conduit. On (b)(6) 2016, the hospital operating room had 2 sorin heater-cooler unit devices (manufactured in (b)(4)) in use. The devices were not identified by ceid or s/n in the patient's medical record. The operating room used one of the two sorin devices listed below: clinical engineering id (ceid) #'s: (b)(4); s/n (b)(4), and (b)(4); s/n (b)(4).

 
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Brand NameSORIN STOCKERT 3T HEATER-COOLER UNIT DEVICE
Type of DeviceSORIN HEATER COOLER DEVICE
Manufacturer (Section D)
LIVA NOVA PLC
MDR Report Key6885733
MDR Text Key87199002
Report NumberMW5072266
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSEE PAGE 3.
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?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/22/2017 Patient Sequence Number: 1
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