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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 16-02-85
Device Problem Electrical Power Problem (2925)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2016
Event Type  No Answer Provided  
Manufacturer Narrative

There was no patient involvement. 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 sorin group field service representative was dispatched to the facility to investigate. The service representative confirmed that the patient bridge power connector and the ac mains board were burnt. The customer confirmed that the facility had experienced a power surge on the event date. The defective components were replaced and subsequent functional testing did not identify further issues. The was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. No trend has been identified for this type of issue. Sorin group (b)(4) will continue to monitor for trends related to this issue. Evaluated on site by sorin service rep.

 
Event Description

Sorin group (b)(4) received a report that a facility experienced a power surge which burnt the patient bridge power connector and the ac mains board of the sorin heater cooler system 3t during priming. There was no patient involvement.

 
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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 Key6168443
MDR Text Key62377616
Report Number9611109-2016-00910
Device Sequence Number1
Product Code DWC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 11/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number16-02-85
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/08/2008
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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