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

Model Number 25-40-45

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).A distributor engineer visited the facility after the first reports and was unable to reproduce the reported issue.On february 15, 2017, the issue was reported again and the distributor engineer was able to confirm the reported issue.The engineer observed that the air flow was configured at 5ml and measured 0ml at the air flow detector.The oxygenator was disconnected and the flow increased to 2ml.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The s5 gas blender system has been requested for return to (b)(4) for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

(b)(4) received a report that the s5 gas blender system did not deliver the correct air flow.This issue reportedly occurred during multiple procedures over the course of a month.There was no report of patient injury.

• 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 80004 ; 2812287280
• MDR Report Key: 6457196
• MDR Text Key: 71831689
• Report Number: 9611109-2017-00303
• Device Sequence Number: 1
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: 010403381790069611160329
• Combination Product (y/n): N
• Reporter Country Code: CS
• 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
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2016
• 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