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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 Date 05/17/2017
Event Type  malfunction  
Manufacturer Narrative
The gasblender was returned to livanova (b)(4) for further investigation. The investigation confirmed the reported failure and traced the issue back to the presence of high amount of dust in the device. The claimed units has then been cleaned and disinfected to solve the reported issue. Subsequent functional verification testing was completed without further issues and the unit was returned to service. A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
 
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). This medwatch report is being filed on behalf of livanova (b)(4). The investigation is on-going. If any additional information pertinent to the reported event is received, it will be provided in a supplemental report. Device not returned.
 
Event Description
Livanova (b)(4) received a report that a s5 gas blender system displayed an error message during priming. 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 Key6620662
MDR Text Key251906560
Report Number9611109-2017-00419
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 health professional
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
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? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2010
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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