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

Model Number 25-40-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a user report that the blood of the patient became deoxygenated during a procedure that involved an s5 gas blender system.The gas blender was exchanged for a manual gas blender, however the patient oxygen levels did not significantly improve.The electronic gas blender was hooked back up to the patient.After 20 minutes it was possible to deliver oxygenated blood to the patient.There was no report of patient injury.The gas blender was returned to sorin group (b)(4) for further investigation.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a user report that the blood of the patient became deoxygenated during a procedure that involved an s5 gas blender system.The gas blender was exchanged for a manual gas blender, however the patient oxygen levels did not significantly improve.The electronic gas blender was hooked back up to the patient.After 20 minutes it was possible to deliver oxygenated blood to the patient.There was no report of patient injury.

Manufacturer Narrative

The manufacture date provided in the initial report, submitted on june 7, 2016, was incorrect.The correct manufacture date is: december 10, 2013.

Manufacturer Narrative

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 user report that the blood of the patient became deoxygenated during a procedure that involved an s5 gas blender system.The gas blender was exchanged for a manual gas blender, however the patient oxygen levels did not significantly improve.The electronic gas blender was hooked back up to the patient.After 20 minutes it was possible to deliver oxygenated blood to the patient.There was no report of patient injury.The gas blender was returned to sorin group (b)(4) for investigation.Visual inspection did not identify any defects or abnormalities, however the reported issue was confirmed during functional testing.The air valve and the mass-flow meter/controllers for air and o2 were replaced and a functional check and a new calibration was performed.Functional control and a technical safety inspection were 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; sorin group deutschland; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5705091
• MDR Text Key: 46760691
• Report Number: 9611109-2016-00340
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2016
• 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
• Patient Outcome(s): Other