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 07/29/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that some of the s5 gas blender fio2 measurements were out of spec during a preventive maintenance check.There was no pt involvement.

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 (b)(4) received a report that some of the s5 gas blender fio2 measurements were of out spec during a preventive maintenance check.There was no pt involvement.The investigation is ongoing.A follow up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) received a report that some of the s5 gas blender fio2 measurements were out of specification during a preventive maintenance check.There was no patient involvement.The involved gas blender was returned to sorin group (b)(4) for evaluation.Testing of the returned unit confirmed the reported issue and found it was caused by a problem with the flow control.The flow control was replaced and subsequent testing confirmed that the issue was resolved.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 coorhees, mgr, quality as ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4046934
• MDR Text Key: 4738842
• Report Number: 1718850-2014-00297
• 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: 07/29/2014

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: 25-40-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2006
• 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