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

Model Number 48-40-00

Device Problems Device Operates Differently Than Expected (2913); Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

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 sensor of sorin s5 system did not stop the pump during a procedure.The customer reported that the level sensor was assigned to the pump, but became unassigned on its own during the case.There was no report of patient injury.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 level sensor of sorin s5 system did not stop the pump during a procedure.The customer reported that the level sensor was assigned to the pump, but became unassigned on its own during the case.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of livanova (b)(4).A video was provided to livanova (b)(4) for investigation.The video was analyzed and it shows a pump with a link to the bubble measurement and pressure measurement.The pump does not have a link to level measurement.The level sensor is activated ¿ an acoustic alarm is sounding ¿ but it is not connected to the shown pump.The readouts taken also revealed nothing unusual; the level sensor module did not save any timeouts, meaning the module and its function were without failure.The videos were reviewed several times, but unfortunately the video only showed the pump display without the symbol and did not capture the event of the symbol disappearing.The exact root cause is unknown.However, attempts were made to reproduce the problem at livanova (b)(4) without success.Different software versions of the level module were tested and no issues were noted, leading the investigator to exclude software or hardware problems as the cause.The error was resolved by restarting s5 system, which indicates that there were old or double registrations, or that the configuration had not been checked correctly.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The customer stated that the device will be monitored and if the issue recurs, the whole system will be made available for return.

• 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): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5852024
• MDR Text Key: 51343060
• Report Number: 9611109-2016-00488
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/25/2017

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: 07/13/2016
• Initial Date FDA Received: 08/05/2016
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• 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