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

Model Number 48-40-00

Device Problem Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

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).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the level control of the sorin s5 system failed to stop or control the arterial pump when the level alarm sounded and the level display became red during a procedure.The pump was stopped manually and there was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate, but was unable to reproduce the reported issue.The level alarm and the link with the roller pump performed as expected.All relevant connections were checked and no loose plugs or connectors were discovered.The roller pump was inspected internally and the level module was tested; no abnormalities were found.A serial readout was performed and sent to sorin group (b)(4) for evaluation which was unable to identify any software or hardware errors.The pump software was updated and the unit was released to the customer.As the issue was not reproduced, a root cause could not be determined and no corrective actions were identified.A review of the dhr was unable to identify any deviations or non-conformities relevant to the issue.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.Service inspected the device on site.

Event Description

Sorin group (b)(4) received a report that the level control of the sorin s5 system failed to stop or control the arterial pump when the level alarm sounded and the level display became red during a procedure.The pump was stopped manually and 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: 5575169
• MDR Text Key: 42612905
• Report Number: 9611109-2016-00184
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/14/2016

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• 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