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U.S. Department of Health and Human Services

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

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SORIN GROUP DEUTSCHLAND SORIN HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 06/01/2012
Event Type  Death  
Manufacturer Narrative
The model number was not provided, so it is unclear whether a sorin heater-cooler system 3t (510k#: k052601) or a sorin heater-cooler system 1t (not distributed in usa) was involved. This information will be provided in a supplemental report if and when made available. The model and serial number were not disclosed by the facility. This will be provided in a supplemental report if and when made available. The model number was not provided, so the 510(k) number is unknown. This will be provided in a supplemental report if and when made available. The serial number was not provided, so the manufacture date is unknown. This will be provided in a supplemental report if and when made available. Sorin group (b)(4) manufactures the sorin heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that a patient experienced mycobacteria chimaera endocarditis in association with a surgical procedure performed in (b)(6) 2012 that utilized a sorin heater-cooler system. The patient (b)(6), who had an aortic valve endoprosthesis, was hospitalized on (b)(6) 2015 for endocarditis, paravalvular leakage and paravalvular abscess with sepsis. The aortic valve was replaced on the same day. The following day, (b)(6) 2015, the patient expired due to the post-operative infection. The aortic valve tissue underwent microbiological examination on (b)(6) 2015. A high number of acid-fast rods were identified. Mycobacteria chimaera could be confirmed via dna sequencing. The result was also confirmed by the national reference center (nrc) for mycobacteria (borstel). Based on these results, the customer came to the conclusion that the infection was caused by m. Chimaera. Attempts at culturing have failed so far. The model and serial number have not been provided by the facility. The facility owns both sorin heater-cooler system 3t units and sorin heater-cooler system 1t units (which are not distributed in the usa), so it is unknown which system was involved in the event. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that a patient experienced mycobacteria chimaera endocarditis in association with a surgical procedure performed in (b)(6) 2012 that utilized a sorin heater-cooler system. The patient (b)(6), who had an aortic valve endoprosthesis, was hospitalized on (b)(6) 2015 for endocarditis, paravalvular leakage and paravalvular abscess with sepsis. The aortic valve was replaced on the same day. The following day, (b)(6) 2015, the patient expired due to the post-operative infection.
 
Manufacturer Narrative
(b)(4) manufactures the heater-cooler system. The incident occurred in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Several attempts have been made to contact the customer and retrieve additional information regarding patient details and the involved device. No further information was provided during these follow-up attempts. However, during follow-up communication made independently from this event, the customer disclosed that the facility's heater-cooler devices have been removed from service and quarantined by the medical engineering department until a "rework" can be performed. Additional details about the rework and when it will be completed were not provided. No information provided.
 
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Brand NameSORIN HEATER-COOLER SYSTEM
Type of DeviceCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
SORIN GROUP DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key5448313
MDR Text Key38628485
Report Number9611109-2016-00047
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
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: 02/19/2016 Patient Sequence Number: 1
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