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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 07/03/2015
Event Type  Death  
Manufacturer Narrative
The model number and the serial number of the unit were not provided. At the time of the cardiac surgery, the facility ((b)(6)) had three heater-cooler systems. All were model number 16-02-80. The serial numbers for the three units are: (b)(4). (b)(6). The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601). Device manufacture dates for the three units in use at the time of the initial surgery: (b)(4)- may 2003; (b)(4)- december 2005; (b)(4)- december 2005. 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 through follow-up communication with the customer, sorin group (b)(4) learned that the facility ((b)(6)) has no records of which device was used on the patient. The customer stated that all three units in use by the hospital at the time of the surgery in (b)(6) 2014 ((b)(4)) were scrapped and replaced in 2015. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
On october 25, 2016, sorin group (b)(4) received a medsun report (mw5065481) stating that a patient died from a nontuberculous bacteria infection after undergoing an aortic heart valve replacement in (b)(6) 2014. The patient was incorrectly diagnosed with sarcoidosis and was prescribed steroids and methotrexate, which lead to a rapid decline. On (b)(6) 2016, sorin group received a user report from the (b)(6) related to the same case, which contained additional information. The report stated that the patient expired on (b)(6) 2016 from endocarditis caused by mycobacterium chimaera at (b)(6) hospital in (b)(6). The report stated that the original surgery took place at (b)(6). Both reports were issued by a family member of the patient.
 
Manufacturer Narrative
(b)(4) manufactures the heater-cooler system 3t. The incident occurred in (b)(6). This medwatch report is being filed on behalf of (b)(4). (b)(4) has not received any additional information regarding test results or the cleaning procedures for any of the heater-cooler devices in use at the time of the patient surgery. All three units in use at the time of surgery have been scrapped by the facility. The dhr and service history reviews for each device did not identify any deviations or non-conformities relevant to the reported issue. An exact root cause for the contamination was not identified. However, as corrective action for this type of issue, a field safety notice has been released to remind our customers about the importance of adhering to the water management and disinfection procedure outlined in the current instructions for use (ifu). Devices discarded.
 
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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)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6119352
MDR Text Key60619182
Report Number9611109-2016-00770
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient Family Member or Friend
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2017
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: 11/21/2016 Patient Sequence Number: 1
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