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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
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 05/01/2014
Event Type  Death  
Manufacturer Narrative
Patient age and weight were not provided. Exact event date (date patient diagnosed with infection) is unknown. Patient underwent surgery on (b)(6) 2014 and was diagnosed with infection approximately 4 to 6 weeks later. The model and serial number have not been provided and the udi could not be determined. This information will be provided in a supplemental report if and when made available. The serial number was not provided, so it is unknown if the unit has already been returned or not. This information will be provided in a supplemental report if and when made available. The serial number was not provided, so the manufacture date could not be determined. This information 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). On july 8, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on june 28, 2016. After receiving and reviewing the legal complaint against our complaints records, it is our belief, based on the current information provided to date, that the legal complaint identified one of the 15 patients who was reportedly infected with mycobacterium at (b)(6) hospital (see medwatch report 1718850-2014-00398 for original report). The patient tested positive for a mycobacterium abscessus sternal wound infection approximately 4 to 6 weeks after undergoing a coronary artery bypass grafting procedure on (b)(6) 2014 involving a sorin heater-cooler system 3t. The patient expired on (b)(6) 2014. Risk management and legal representatives from the facility have confirmed that an independent engineering expert engaged by the hospital has excluded the sorin heater-cooler device as a contributing factor. Risk management noted that the engineer ran dye through the device and found no leakage, concluding that no bacteria could leak from the device. Furthermore, public statements released by the facility on july 26, 2014, indicate "officials have linked the infection, mycobacterium abscessus, to tap water at (b)(6) hospital", and that it is "unlikely that the equipment allowed tap water to contact patients. " sorin has previously contacted the facility and inquired if the equipment was available for return sorin group (b)(4) for further evaluation. No request has been made by the facility.
 
Event Description
On july 8, 2016, sorin group (b)(4) was notified of a legal complaint that was filed on june 28, 2016. After receiving and reviewing the legal complaint against our complaints records, it is our belief, based on the current information provided to date, that the legal complaint identified one of the 15 patients who was reportedly infected with mycobacterium at (b)(6) hospital (see medwatch report 1718850-2014-00398 for original report). The patient tested positive for a mycobacterium abscessus sternal wound infection approximately 4 to 6 weeks after undergoing a coronary artery bypass grafting procedure on (b)(6) 2014 involving a sorin heater-cooler system 3t. The patient expired on (b)(6) 2014.
 
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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
lindbergstr. 25
munich, 80939
GM 80939
Manufacturer Contact
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5873527
MDR Text Key52056424
Report Number9611109-2016-00563
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 other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received07/08/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/12/2016 Patient Sequence Number: 1
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