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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 Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement. Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). A review of the dhr could not identify any deviations or nonconformities relevant to the issue a field service technician was dispatched to the facility to investigate the device and was not able to reproduce the reported issue. He tested the unit and when the flow rate of o2+ air fell below the set value the alarm properly worked. As results of the service activity no abnormalities were found. Based on the information available, it cannot be ruled out that a user error during the set-up phase led to the reported issue.
 
Event Description
Livanova received a report stating that no alarm sounded when the o2 and air connectors were removed from the s5 gas blender. The issue occurred during set-up after the setting of the output value. 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 80309
GM 80309
Manufacturer (Section G)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich 80309
GM 80309
Manufacturer Contact
enrico greco
14401 w. 65th way
arvada, CO 80004
MDR Report Key10090651
MDR Text Key194051938
Report Number9611109-2020-00321
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 05/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2020
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? No
Event Location No Information
Date Manufacturer Received04/01/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/16/2016
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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