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U.S. Department of Health and Human Services

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

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LIVANOVA 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 Type  malfunction  
Manufacturer Narrative
During the investigation the reported failure could be confirmed. A deviation of the oxygen flow was detected and as root cause a defective mass flow controller could be identified. The defective part was replaced to resolve the reported issue. Subsequent functional verification testing and a calibration was completed without further issues and the unit was returned to service. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
Manufacturer Narrative
There was no patient involvement. Date of event is unknown. This information will be provided in a supplemental report if made available. Livanova (b)(4) manufactures the s5 gas blender. The incident occurred in barcelona(b)(6). The device was returned to livanova (b)(4) for further investigation. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report that a s5 gas blender system displayed an error message during maintenance. There was no patient involvement.
 
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Brand NameS5 GAS BLENDER SYSTEM
Type of DeviceGAS CONTROL UNIT, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80939
GM 80939
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key7124847
MDR Text Key264138177
Report Number9611109-2017-01015
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
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 Manufacturer11/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/12/2011
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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