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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
Catalog Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 12/15/2013
Event Type  Injury  
Manufacturer Narrative
The model and serial number of the involved unit have not been disclosed by the facility. This information will be provided in a follow-up report if and when made available. Pma 510(k): the model number has not been disclosed by the facility, so the 510(k) number is unknown. Mfg date: the serial number has not been disclosed by the facility, so the manufacture date is unknown. 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. Sorin group (b)(4) received a user medwatch report (mw5058674) stating that the patient displayed a polymicrobial pectoralis muscle flap infection 3 months following surgery utilizing a sorin heater-cooler system 3t. The investigation is ongoing. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a user medwatch report (mw5058674) stating that the patient displayed a polymicrobial pectoralis muscle flap infection 3 months following surgery utilizing a sorin heater-cooler system 3t.
 
Manufacturer Narrative
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). Several attempts were made to obtain more information about the patient and any potentially involved device(s) from the customer. However, sorin group (b)(4) has not received any further information related to this event. As no additional information has been provided by the customer, no additional investigation can be performed.
 
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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 Key5395177
MDR Text Key36948377
Report Number9611109-2016-00001
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
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 01/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/30/2016
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: 01/27/2016 Patient Sequence Number: 1
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