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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
Model Number 16-02-80
Device Problem Failure to Pump (1502)
Patient Problem No Patient Involvement (2645)
Event Date 08/16/2016
Event Type  No Answer Provided  
Manufacturer Narrative
There was no patient involvement. 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). (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 the sorin heater-cooler system 3t was not pumping on the patient circuit during in-service. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate. The customer clarified at that time that the issue they had with the unit was that it was not warming to 37 degrees. The technician tested the system by switching between cold and hot. The system displayed an error when switching to hot and stopped pumping. However, clearing the error resolved the issue and the system began functioning as expected. The service representative checked the calibration and tested the system again without issue. The reported issue was not reproduced; the unit was able to reach and maintain the set temperature. As the issue could not be confirmed, a root cause was not determined and no corrective actions were identified. A review of the dhr has not yet been performed. A follow-up report will be submitted upon completion of the dhr review. Evaluated on site by sorin service rep.
 
Event Description
Sorin group (b)(4) received a report that the sorin heater-cooler system 3t was not pumping on the patient circuit during in-service. There was no patient involvement.
 
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). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Evaluated on site by sorin service rep.
 
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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 Key5956899
MDR Text Key54997030
Report Number9611109-2016-00646
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 health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16-02-80
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2001
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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