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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 Operational Issue (2914)
Patient Problem No Patient Involvement (2645)
Event Date 09/26/2016
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Initial reporter. The event was discovered and reported by an employee of sorin group (b)(4). However, the device had been returned by (b)(6) for an unrelated issue. Sorin group (b)(4) manufactures the s5 gas blender system. The incident occurred (b)(6). This medwatch report is being filed on behalf of sorin group (b)(4). During complaint investigation and testing s5 gas blender system returned for an unrelated complaint, an alarm sounded and the values for air and o2 blinked. This issue was discovered during complaint investigation at sorin group (b)(4). There was no patient involvement. The sorin technician traced the failure to a defective mass flow controller. The faulty component was replaced and a subsequent 24 hour test run did not identify further issues. A new calibration, functional control and technical safety inspection were carried out without issue and the device was 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.
 
Event Description
During complaint investigation and testing s5 gas blender system returned for an unrelated complaint, an alarm sounded and the values for air and o2 blinked. This issue was discovered during complaint investigation at sorin group (b)(4). 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
lindbergstr. 25
munich, 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6046854
MDR Text Key58055970
Report Number9611109-2016-00688
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2016
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 Manufacturer09/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2016
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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