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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

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SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 25-40-45
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 08/05/2016
Event Type  No Answer Provided  
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 gas blender system. The incident occured in (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). Sorin group (b)(4) received a report that s5 gas blender system did not deliver the selected gas flow during priming. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate. The service representative inspected the unit and tested the gas flow and all results were found to be within the specified parameters. The issue could not be reproduced or confirmed. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. Sorin group (b)(4) will continue to monitor for trends related to this type of issue. Evaluated on site by sorin service rep.
 
Event Description
Sorin group (b)(4) received a report that s5 gas blender system did not deliver the selected gas flow during priming. There was no patient involvement.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, 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
carrie wood
14401 w. 65th way
arvada, CO 80004
3034676461
MDR Report Key5912630
MDR Text Key53502383
Report Number9611109-2016-00564
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K101046
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
Report Date 08/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number25-40-45
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 Received08/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2012
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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