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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 Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2016
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. 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 received a report that the oxygenator did not receive significant flow from the s5 gas blender system during a procedure. An alternative gas blender was connected and the oxygenator began receiving the correct flow. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate. The service representative performed a soak test for 2 hours at various flows and gas mix settings and was unable to reproduce the reported issue. The unit was replaced with a loan unit and was returned to sorin group (b)(4) for investigation. The investigation is still ongoing. A follow-up will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the oxygenator did not receive significant flow from the s5 gas blender system during a procedure. An alternative gas blender was connected and the oxygenator began receiving the correct flow. There was no patient involvement.
 
Manufacturer Narrative
Sorin group (b)(4) manufactures the s5 gas blender system. The incident occured in (b)(6). This medwatch is being filed on behalf of sorin group (b)(4). The complained gas blender was returned to sorin group (b)(4) for investigation. The reported issue was confirmed during functional testing and could be traced to several defective components. The mass-flow meter/controller for air and o2, the eprom and the front panel were replaced and a functional check and new calibration were performed. Functional control and a technical safety inspection were successfully carried out and no further issues were discovered. The device was cleaned and disinfected and returned to the customer. 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.
 
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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
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key5941122
MDR Text Key54411847
Report Number9611109-2016-00292
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,Followup
Report Date 04/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2012
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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