MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 GAS BLENDER SYSTEM GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problems Device Displays Incorrect Message (2591); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement. Initial contact telephone number: (b)(6). Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in bad (b)64). This medwatch report is being filed on behalf of livanova (b)(4). A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue. The device has been returned to livanova (b)(4) for evaluation. 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 s5 gas blender system displayed an error message could not be adjusted during priming. There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 gas blender system. The incident occurred in (b)(6). The device was sent to livanova (b)(4) for investigation. The service engineer inspected the device and was able to confirm the reported issue. During inspection, the calibration showed a deviaition in the o2 flow and the temperature sensor was identified as not working properly. The measurement bridge, the mass flow controller and the front panel required replacement. After the replacement of the parts, a recalibration, and a functional check were performed with no further issue. The device was returned to service.

• Brand Name: S5 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: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6822567
• Report Number: 9611109-2017-00667
• Device Sequence Number: 1
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: 010403381790069611160509
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse