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

Model Number 25-40-45

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2017

Event Type  malfunction  

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).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information relevant to the reported issue is received, it will be provided in a supplemental report.Device not returned.

Event Description

Livanova (b)(4) received a report that the s5 gas blender system gave false readings at low sweep settings (below 1.3) during a procedure.The customer reported that the readings fluctuated up and down randomly until the sweep setting was brought above 1.4, at which point the device functionality returned to normal.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).Livanova (b)(4) received a report that the s5 gas blender displays false readings.The gas blender was fluctuating randomly up and down at low sweep settings (1.3 and lower) with alarm.Sweep settings at 1.4 and higher were not affected.There was no patient or user injury as a result of this event.A livanova field service engineer sent a video of the event to the tssi department of livanova (b)(4).The tssi service engineer noted that the unit was at the low end of approved use.This behavior was normal because of the usage curve.This problem analysis solved the issue.The root cause was determined to be related to user techniques as the problem was traced back to the problem that the gas blender was used at low end of approved use.Since no specific trend could be identified for this type of issue, livanova (b)(4) has determined that a capa is not needed.

• 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: 6744206
• MDR Text Key: 81156280
• Report Number: 9611109-2017-00572
• Device Sequence Number: 1
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: 010403381790069611160811
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/07/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2016
• 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