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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 04/17/2015
Event Type  Death  
Manufacturer Narrative
The model and serial number were not provided in the user report, and the unique identifier (udi) number could not be determined. This information will be provided in a supplemental report if and when made available. As the serial number was not provided, the device 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). (b)(4). Through follow-up communication with the reporting facility, sorin group (b)(4) learned that the original cardiac bypass surgery was performed at the (b)(6) hospital in (b)(6) on (b)(6) 2015. The patient was admitted to the (b)(6) university on (b)(6) 2016, where a complicated washout/debridement of the mediastinal infection was performed. The patient died on (b)(6) 2016 at the age of (b)(6) years. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
On november 28, 2016, sorin group (b)(4) received a user medwatch report (mw5066126) stating that a patient presented with a non-tuberculous mycobacterium infection after undergoing cardiac bypass surgery a year prior at a different facility. The patient died from the complications of the infection.
 
Manufacturer Narrative
During a complaint review conducted on july 13, 2017, it was discovered that this issue has been previously reported by another facility ((b)(6), where the surgical procedure took place) on user medwatch report (b)(4) and on the manufacturer report 9611109-2016-00775. The details of the two reports have been combined and will be submitted under 9611109-2016-00775. This medwatch report number is void as a duplicate.
 
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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,
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 Key6202790
MDR Text Key63236022
Report Number9611109-2016-00887
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2016
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 Received07/13/2017
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: 12/23/2016 Patient Sequence Number: 1
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