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

Model Number 25-40-45

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 gas blender system alarmed when co2 was introduced.There was no report of patient injury.A loaner unit has been provided and the complained unit has been requested for return to sorin group (b)(4) for evaluation.The investigation is still on-going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the s5 gas blender system alarmed when co2 was introduced.There was no report of patient injury.

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 livanova (b)(4).The reported device was returned to livanova (b)(4) for further investigation.During visual inspection, a damaged front panel was identified.However, the issue was not reproduced during functional testing.The calibration was renewed and a technical safety inspection was successfully carried out.The unit was returned to the customer.As the issue was not reproduced, a root cause could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP 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: 5880952
• MDR Text Key: 52282721
• Report Number: 9611109-2016-00510
• Device Sequence Number: 1
• Product Code: DTX
• 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: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2007
• 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