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

Model Number 25-40-45

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2016

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 received a report that the oxygenator did not receive significant flow from the s5 gas blender system during a procedure.An alternative gas blender was connected and the oxygenator began receiving the correct flow.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The service representative performed a soak test for 2 hours at various flows and gas mix settings and was unable to reproduce the reported issue.The unit was replaced with a loan unit and was returned to sorin group (b)(4) for investigation.The investigation is still ongoing.A follow-up will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the oxygenator did not receive significant flow from the s5 gas blender system during a procedure.An alternative gas blender was connected and the oxygenator began receiving the correct flow.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender system.The incident occured in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).The complained gas blender was returned to sorin group (b)(4) for investigation.The reported issue was confirmed during functional testing and could be traced to several defective components.The mass-flow meter/controller for air and o2, the eprom and the front panel were replaced and a functional check and new calibration were performed.Functional control and a technical safety inspection were successfully carried out and no further issues were discovered.The device was cleaned and disinfected and returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor for trends related to this type of 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): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5941122
• MDR Text Key: 54411847
• Report Number: 9611109-2016-00292
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2012
• 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