MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND 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 04/23/2015

Event Type  malfunction  

Event Description

Sorin group received a report that the gas flow through the gas blender was fluctuating during a procedure.The patient was not affected.

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)(4).Sorin group received a report that the gas flow through the gas blender was fluctuating during a procedure.The patient was not affected.The issue is currently under investigation.A follow-up report will be sent when the investigation is complete.

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)(4).Sorin group received a report that the gas flow through the gas blender was fluctuating during a procedure.The patient was not affected.The device was returned to sorin group (b)(4) and then sent to the supplier for further investigation.The reported failure could not be reproduced.The unit was calibrated and tested.A run for 24 hours with different interventions was performed and no deviations or errors were found.A review of the device history record showed no deviations or nonconformities with regard to this issue.The issue will be trended and if identified corrective action will be recommended.

Event Description

Sorin group received a report that the gas flow through the gas blender was fluctuating during a procedure.The patient was not affected.

• Brand Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; d 80939 munich, D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; d 80939 munich, D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees ; 14401 west 65th way; arvada, CO 84005 ; 3034676527
• MDR Report Key: 4796059
• MDR Text Key: 20361759
• Report Number: 9611109-2015-00146
• 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
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• 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
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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