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

Model Number 48-40-00

Device Problems Mechanical Problem (1384); Improper Device Output (2953); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The report indicates that the device is available for evaluation, however a device was already returned to sorin group (b)(4) on january 20, 2015.The returned device has already been evaluated at sorin and returned to the customer.It is not clear if a device is currently available.Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a user medwatch report (b)(4) on (b)(6) 2016 stating that the sorin s5 system made a noise during a procedure that was disturbing to the surgeon.It was also reported that the rpms were erratic, but it is unknown on which pump this issue occurred.The customer also reported that the pump was found to have fluid invasion and failed to show rpms.It is unknown on which pump this issue occurred.The customer expressed concern with the poor sealing of the centrifugal pump drive, allowing liquid to enter the housing.The customer also expressed concern with the power switch, which does not have guards to protect against an accidental power down, as well as the response time of the pressure monitoring system and the drive dial for the centrifugal pump, which the customer stated had delayed response.There was no report of patient injury.It is unknown what specific issues occurred during the procedure documented in the user medwatch report (only one alert date was provided), or whether all of the reported issues occurred on the same unit.It is also not known, at this time, if the facility requires service for the reported issues.Multiple attempts have been made to contact the perfusionist to obtain more information about the incident.However, none of these attempts have been successful.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a user medwatch report (b)(4) on (b)(6) 2016 stating that the sorin s5 system made a noise during a procedure that was disturbing to the surgeon.It was also reported that the rpms were erratic, but it is unknown which pump this issue occurred on.The customer also reported that the pump was found to have fluid invasion and failed to show rpms.It is unknown which pump this issue occurred on.The customer expressed concern with the poor sealing of the centrifugal pump drive, allowing liquid to enter the housing.The customer also expressed concern with the power switch, which does not have guards to protect against an accidental power down, as well as the response time of the pressure monitoring system and the drive dial for the centrifugal pump, which the customer stated had delayed response.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 being filed on behalf of livanova (b)(4).The various issues with the device mentioned in the user medwatch report were reviewed by livanova deutschland.The following information was identified: in 2008, a design change was made to prevent fluid ingress into the cp5 housing.After the design change, the labels were changed to contain ipx-2 water proof standard, indicating that the centrifugal pump has no risk of fluid ingress when it is tilted up to 15° from normal position.If the position of the pump exceeds related angle, housing is no longer protective.The on/off switch is embedded about a centimeter deep into the housing to reduce the possibility that the switch will be activated accidentally during rpm adjustment (either increasing or decreasing), the motor of the drive unit needs time to stabilize to the required speed.The average time delay is a maximum of three seconds for any input parameter alterations.In the event of an alarm, the maximum delay is one second.This reported delay is within design tolerance and is considered normal.Based on the evaluation, the conditions noted by the customer are either by design or have been addressed in product improvements since the release of the pump.For this reason, livanova (b)(4) has concluded that the main root cause is customer perception or use issue.The customer stated that previous complaints existed for liquid ingress and loose connections, but did not provide a serial number for the unit and related complaints could not be evaluated.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Perception issue.

• 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: 5699486
• MDR Text Key: 46569160
• Report Number: 9611109-2016-00311
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 48-40-00
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2012
• 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