MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 48-40-00

Device Problems Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that the centrifugal pump controller of the sorin s5 system did not respond for several seconds when trying to increase speed past 1000rpm during a procedure.The pump responded after 3 to 5 seconds and the case was completed without further issue.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate the issue.The service representative tested the scp system attached to the sorin s5 system and was unable to reproduce the described issue.The device was found to be working according to specification.The unit was returned to service.As the issue could not be reproduced, a root cause could not be determined and no corrective actions were identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.No trend was identified for this type of issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Device evaluated on site by sorin service rep.

Event Description

Sorin group (b)(4) received a report that the centrifugal pump controller of the sorin s5 system did not respond for several seconds when trying to increase speed past 1000rpm during a procedure.The pump responded after 3 to 5 seconds and the case was completed without further issue.There was no report of patient injury.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 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: 5699458
• MDR Text Key: 46565177
• Report Number: 9611109-2016-00310
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• 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
• Report Date: 05/06/2016

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: 48-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2009
• 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