MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 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 08/28/2014

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the oxygen value of the s5 gas blender was out of specification during a preventive maintenance.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufacturers the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

(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 (b)(4) received a report that the oxygen value of the s5 gas blender was out of specification.During a preventive maintenance.The gas blender was sent to sorin group (b)(4) for evaluation.The reported issue could not be reproduced.The unit was calibrated and tested.A test run for 24 hours with different interventions was performed.During this time no deviations or errors were found.No nonconformities were noted during manufacturing record review.The issue will be monitored for trends and if identified, corrections will be recommended.

• 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. ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4254823
• MDR Text Key: 5044469
• Report Number: 1718850-2014-00420
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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