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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 16-02-85
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Death (1802)
Event Date 03/29/2016
Event Type  Death  
Manufacturer Narrative
Patient identifier was not disclosed. Patient weight was stated as unknown in the user report. The event date in the user medwatch report was listed as the date of the procedure ((b)(6) 2011). However, we have selected the event date to be the day when the patient presented with symptoms ((b)(6) 2916). The serial number of the involved device is unknown. This information will be provided in a supplemental report if and when made available. As the serial number is unknown, the device manufacture date could not be determined. This information will be provided in a supplemental report if and when made available. (b)(4). Through follow-up communication with the customer, sorin group deutschland learned that the units in use at the facility at the time of the surgery have been tested. However, the test results have not been provided. The contact stated that the units are not tested on a regular basis. The customer reported that one new device has been obtained. However, all of the units are still in use and are operated within the or. Circumstances surrounding the patient's death are unknown at this time. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
On january 6, 2017, sorin group (b)(4) received a user medwatch report (b)(4) stating that a patient presented with symptoms of infection on (b)(6) 2016 after undergoing a coronary artery bypass grafting procedure on (b)(6) 2011 that included the use of a sorin heater-cooler system 3t. The symptoms included general malaise, weakness, fatigue and poor oral intake. Blood cultures were taken on (b)(6) 2016 and tested positive for mycobacterium avium complex. The report stated that additional testing of blood cultures is being conducted. The patient was reported to have expired 5 months after presenting with symptoms, on (b)(6) 2016. The exact cause of death was not reported.
 
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Brand NameSORIN HEATER-COOLER SYSTEM 3T
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6300480
MDR Text Key66479085
Report Number9611109-2017-00018
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Risk Manager
Remedial Action Other
Type of Report Initial
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-02-85
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/03/2017 Patient Sequence Number: 1
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