MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-28-67

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

Patient Problem No Patient involvement (2648)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

Sorin group representative was at a customer site evaluating a system to be used for training.It was found that the electronic blender was not flowing correctly.There was no patient involvement.

Manufacturer Narrative

Patient information was not provided.Manufacturing date was not provided.It will be forwarded when received.Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group representative was at a customer site evaluating a system to be used for training.It was found that the electronic blender was not flowing correctly.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

The device manufacture date was inadvertently not included on the initial report.The device manufacture date is march 10, 2011.Livanova (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 s5 gas blender system was returned to livanova (b)(4) for further investigation.The reported issue could be reproduced during testing.The gas and o2 controller were found to be faulty and were replaced.The s5 gas blender system was tested without further issue and was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: S5 SYSTEM AND GAS BLENDER AND SORIN C5 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 4910250
• MDR Text Key: 6834936
• Report Number: 9611109-2015-00263
• Device Sequence Number: 1
• Product Code: DWA
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-28-67
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2011
• 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