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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 No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2017
Event Type  malfunction  
Manufacturer Narrative
The reported s5 gas blender system was returned for investigation. During the functional test of the device it was not possible to reproduce the reported issue. No deviation could be identified. A routine maintenance and re-calibration was carried out. Subsequent functional verification testing 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
Patient information was not provided. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). Livanova (b)(4) requested the device for further evaluation. A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. 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 had flow issues. When the flow amount was low the flow became zero and the device alarmed. This issue occurred several times after rebooting the device. There was no report of patient injury.
 
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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 Key7082131
MDR Text Key267019993
Report Number9611109-2017-00962
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
Reporter Country CodeJA
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 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
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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