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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN SORIN 3T HEATER COOLER

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SORIN SORIN 3T HEATER COOLER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 06/14/2016
Event Type  Injury  
Event Description

A pt had positive cultures for mycobacterium fortuitum following multiple open heart procedures that utilized a sorin 3t heater cooler device. The pt initially presented for a left ventricular assist device implantation on (b)(6) 2016. The pt returned to the operating room on (b)(6) 2016 to undergo a left ventricular assist device pump exchange due to suspected clot formation in the device. At this time, a right ventricular assist device was placed in addition to a new left ventricular assist device. The pt returned to the operating room a third time on (b)(6) 2016 for a mediastinal exploration. The pt returned to the operating room a fourth time on (b)(6) 2016 to have the right ventricular assist device removed and left the operating room with an open chest. On (b)(6) 2016, the pt returned to the operating room for a chest closure/muscle flap. On (b)(6) 2016, the pt was taken to the operating room a sixth time for an egd/peg placement. The pt developed a sternal wound infection and was taken back to the operating room on (b)(6) 2016 for a sternal wound debridement. The pt returned to the operating room on (b)(6) 2016 and (b)(6) 2016 for a sternal closure/muscle flap. Cultures for mycobacterium were sent on (b)(6) 2016. The results from the culture were reported as positive on (b)(6) 2016. The pt was transferred to a rehabilitation center on (b)(6) 2016. This pt experienced a prolonged hospital stay, and add'l surgical operations as a result of the mycobacterium infection. Sorin 3t heater coolers have been reported in literature as a potential source for mycobacterium infection in pts undergoing open heart procedures. To date (07/14/2016), all mycobacterium cultures from the sorin 3t machine used on this pt have resulted negative. Cleaning records have been maintained and the machine that was used on this pt has been pulled from use to undergo extensive testing and subsequent cleaning and disinfection. The results of these tests have not been resulted as of today, 07/14/2016.

 
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Brand NameSORIN
Type of Device3T HEATER COOLER
Manufacturer (Section D)
SORIN
munich, de
GM
MDR Report Key5802596
MDR Text Key49973188
Report NumberMW5063488
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/14/2016 Patient Sequence Number: 1
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