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

Model Number 25-40-45

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 06/10/2015

Event Type  Other  

Event Description

Sorin group received a report that during setup, there was no gas flow from the gas blender and an error alarm occurred.There was no patient involvement.

Manufacturer Narrative

(b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the gas blender.The incident occurred in dublin, ireland.This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that during setup, there was no gas flow from the gas blender and an error alarm occurred.There was no patient involvement.The device was returned to sorin group (b)(4) for investigation.Visual inspection and functional evaluation were unable to reproduce the reported issue.All of the tests performed were error-free.A test run of 24 hours was unable to identify any deviations.A review of the dhr could not identify any deviations or nonconformities relevant to the reported failure.No trend has been identified for this type of issue.Sorin group deutschland will continue to monitor the market for trends related to this issue.

• Brand Name: S5 ELECTRONIC GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4913583
• MDR Text Key: 17940197
• Report Number: 9611109-2015-00227
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• 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
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2006
• 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