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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 Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/15/2016
Event Type  malfunction  
Manufacturer Narrative
Device has been requested, but has not yet been returned to sorin group (b)(4). 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 the an error message was displayed on the hlm system panel during priming. The s5 gas blender system was disconnected from the hlm and the error message was no longer displayed. There was no patient involvement. A sorin group field service representative was dispatched to the facility to investigate and was able to confirm the reported error. Visual inspection revealed extensive corrosion on the gas blender casing and around the electrical plug and multiple other connections. The unit was replaced and subsequent functional checks found no further issues. The device has been requested for return to sorin group (b)(4) for investigation. A follow-up report will be sent when the investigation is complete.
 
Event Description
Sorin group (b)(4) received a report that the an error message was displayed on the hlm system panel during priming. The s5 gas blender system was disconnected from the hlm and the error message was no longer displayed. 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 report is being filed on behalf of sorin group (b)(4). The complained gas blender was returned to sorin group (b)(4) for investigation. Visual inspection did not identify any defects or abnormalities and functional testing was unable to reproduce the reported issue. The device worked within specification. A functional check and a new calibration was performed, and functional control and a technical safety inspection were carried out successfully. The device was cleaned and disinfected and returned to the customer. As the issue could not be reproduced, a root cause could not be determined and corrective actions were not identified. 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 Key5645680
MDR Text Key44888950
Report Number9611109-2016-00291
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 04/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2016
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? Yes
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 Manufactured11/05/2007
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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