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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 Problems Air Leak (1008); Use of Device Problem (1670)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2018
Event Type  malfunction  
Manufacturer Narrative
Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). 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 an s5 gas blender system leaked and did not work as expected during priming. There was no patient involvement.
 
Manufacturer Narrative
During the visual inspection fluid ingress was determined, that means fluid was present inside the device. A fluid presence inside the gas blender could be due to the cleaning procedure or to the accidental fall of blood or priming solution during the different phases of the cec. The device, indeed, is not completely watertight. Fluid inside the gas blender could cause short circuits, electrical problems and fluid leakages as in the reported case. A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
 
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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
MDR Report Key7543230
MDR Text Key109231585
Report Number9611109-2018-00985
Device Sequence Number1
Product Code DTX
Combination Product (y/n)N
PMA/PMN Number
K101046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2018
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

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