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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 04/25/2017
Event Type  malfunction  
Manufacturer Narrative
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). Livanova (b)(4) received a report that after turning on the s5 gas blender system it displayed an electrical error e19 and an alarm sounded. They turned off the power once and rebooted, but the electrical error e19 was displayed again. The issue was noted during priming. There was no patient or user injury as a result of this event. The device was returned to livanova (b)(4) for investigation and the described error could be reproduced. The investigator found that the 73-300-141/g measurement bridge awm 5102vn and the 73-300-252 mass flow controller sor-002g o2 required replacement. The parts were replaced and the unit was reassembled and tested. Preventative maintenance, a test run, calibration and a technical safety inspection were performed 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. Livanova (b)(4) will continue to monitor the market for trends related to this type of 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 customer plans to return to device to livanova (b)(4) for 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, during setup, the s5 gas blender system sounded an alarm after 1 to 2 minutes of power and a numerical error code was displayed. The device was restarted and the error appeared again after 2 to 3 minutes. 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,
Manufacturer Contact
joan ceasar
14401 w. 65th way
arvada, CO 80004
2812287260
MDR Report Key6580065
MDR Text Key254222489
Report Number9611109-2017-00411
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 11/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2017
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 Manufacturer05/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2011
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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