MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT S3 GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-00

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 11/22/2014

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the s3 gas blender alarmed and lost function during a procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s3 gas blender.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The s3 gas blender is not sold in the united states but it is similar to the s5 gas blender which is sold in the united states.The 510k number for the s5 gas blender is k101046.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4) manufactures the s3 gas blender.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 s3 gas blender alarmed and lost function during a procedure.It alarms and all digital displays flash.When tested on another machine, an error message displayed.The issue was confirmed.The cause was a defective front panel.The panel was replaced and the unit was tested without any problems.No nonconformities were noted during manufacturing record review.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: STOCKERT S3 GAS BLENDER
• 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; lingberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, manager ; 14401 w. 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4392229
• MDR Text Key: 5308713
• Report Number: 1718850-2014-00477
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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