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

Model Number 25-40-45

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Device has not yet been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that during the procedure, oxygen was not being delivered to the oxygenator through the s5 gas blender system.The oxygenator line was hooked up directly to an oxygen line to resolve the issue.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that during the procedure, oxygen was not being delivered to the oxygenator through the s5 gas blender system.The oxygenator line was hooked up directly to an oxygen line to resolve the issue.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that during the procedure, oxygen was not being delivered to the oxygenator through the s5 gas blender system.The oxygenator line was hooked up directly to an oxygen line to resolve the issue.There was no report of patient injury.The complained device was returned to sorin group (b)(4) for investigation.The returned unit was visually inspected and underwent functional testing, during which the reported issue was reproduced.The air valve and mass-flow meter/controller were replaced and a functional check and calibration was performed.No further issues were discovered and the device was cleaned and returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor the market for trends related to this type of 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, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5236825
• MDR Text Key: 31623005
• Report Number: 9611109-2015-00564
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• 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: Reuse
• Patient Sequence Number: 1