MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER 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 Consequences Or Impact To Patient (2199)

Event Date 07/07/2014

Event Type  Other  

Event Description

Sorin group received a report of issues of the s5 gas blender alarming and that it has difficulty running the unit at low flows.There was no report of pt injury.

Manufacturer Narrative

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)(6).Sorin group received a report of issues of the s5 gas blender alarming and that it has difficulty running the unit at low flows.There was no report of pt injury.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the s5 gas blender keeps alarming and that it has difficulty running the unit at low flows.There was no report of patient injury.The involved gas blender was returned to sorin group (b)(4) for evaluation.Testing of the returned unit, including a test run for 24 hours with various interventions was unable to reproduce the reported issue.No problems were found.A review of device history record did not find any deviations or non-conformities related to this issue.Without the ability to reproduce the reported issue, the root cause could not be determined and no corrective actions could be identified.Sorin group (b)(4) will continue to monitor the market for trends related to this issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr 25; munich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr, quality as ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4003556
• MDR Text Key: 16991290
• Report Number: 1718850-2014-00259
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1