MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM; 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 07/29/2014

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that the s5 gas blender displayed an error message and the gas flow stopped during a procedure.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).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

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 the s5 gas blender displayed an error message and the gas flow stopped during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate and was able to confirm the reported issue.The gas blender was removed and a loaner was installed.The replaced unit was returned to sorin group (b)(4) for investigation and repair.The returned device was subjected to a visual inspection, hardware analysis and simulated use testing.Visual inspection did not identify any abnormalities, however the reported error was reproduced during testing.A hardware analysis identified a broken circuit board.The cause of the damage could not be determined.The damaged board was replaced and a functional control, calibration and technical safety inspection were carried out.No further issues were discovered.The device was cleaned and disinfected and returned to the customer.A review of the dhr did not identify deviations or non-conformities relevant to the reported issue.Sorin group (b)(4) will continue to monitor 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
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4054686
• MDR Text Key: 21997389
• Report Number: 1718850-2014-00291
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/30/2014

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: 25-28-67
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/30/2014
• Initial Date FDA Received: 08/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• 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