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

Model Number 48-40-00

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).(b)(4).A sorin group field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported issue.A serial readout of arterial and cardioplegia roller pumps was performed and the history log was downloaded.The data was sent to sorin group (b)(4) for further evaluation and an loaner roller pump was supplied to the customer.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 the s5 roller pump stopped without any alarms or warnings during a procedure.The pump console screen became unresponsive and efforts to restart the pump were unsuccessful.The pump was hand-cranked for 5 minutes before replacing the pump.The second pump was also unresponsive, and the decision was made to swap out the entire sorin s5 system.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 console for 4 pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Livanova received data readout for further evaluation; the error could not be reproduced.After the readout analysis there were no errors registered but it was confirmed that the arterial pump was not correctly assigned to the cardio plegia monitoring as controlled pump #2.In the report, the technician has written that the arterial pump was frozen, no touch failure were saved in the micriocontroller due the master/follower configuration.In this case the system has the possibility to override the alarms or master/follower configurations with the two keys in the front of pump display.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Livanova rep evaluated the device onsite.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich,
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, germany 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6183197
• MDR Text Key: 62696162
• Report Number: 9611109-2016-00825
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2007
• 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
• Patient Age: 75 YR
• Patient Weight: 110