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

Model Number 25-40-45

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.(b)(4).The device has been requested for return 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 alarmed no matter what value setting was input during a procedure.The customer reported that keys were inactive during the alarming and the system had to be turned off to clear the alarm.A system restart was able to resolve the issue for a brief period, but the problem eventually recurred.There was no report of patient injury.

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).The device was received and evaluated by livanova (b)(4).The described error could not be reproduced.Unit was disassembled and reassembled (error not found).The device was connected to a s5 machine and communication was ok and no alarm was shown as described in the reported complaint.The device was disinfected and cleaned; value adjustment was performed for better performance of the device.A functional check and a new calibration was performed.Functional control and tsi performed successfully.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The root cause of the reported issue was not determined as no problem was found.Livanova has determined that a capa is not required, as there was no patient harm reported.Livanova will continue to monitor this issue for trends.

• 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
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6876983
• MDR Text Key: 87341180
• Report Number: 9611109-2017-00731
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2010
• 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