MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-00

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the gas blender system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device.The service representative was not able to confirm the reported issue.As precaution the connecting cable will be replaced.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 gas blender system displayed an error message on the panel as well on the module stating a defective module or sensor and air flow alarm during procedure.After swapping the device during procedure, no alarms were given and procedure could be finished with no further event.During testing after the procedure, the swapped device showed another error as well as the message stating a defective module or sensor.The allegation was made, that the connecting cable is defective.There was no report of patient injury.

• Brand Name: GAS BLENDER SYSTEM
• Type of Device: GAS 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: barbara galasso ; 14401 w. 65th way; arvada, CO
• MDR Report Key: 8909789
• MDR Text Key: 175854296
• Report Number: 9611109-2019-00639
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1