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

Model Number 48-40-00

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Sorin group received a report that the s5 system's pressure monitor did not react quickly enough.It was reported that the slow response resulted in blood being sprayed from the connector prior to the pressure alarm stopping the pump.No hospital personnel were contacted by the blood and there was no report of patient injury.

Manufacturer Narrative

Serial number: the serial number was not provided.Therefore the manufacturer date is unknown.Sorin group (b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

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).The device returned to sorin group usa for further evaluation.An extensive evaluation of the device was conducted on the unit.The analysis found that the unit did alarm and stop appropriately in response to pressure levels exceeding identified limits, but that there was a delay of approximately 3 seconds.This delay is intended and is caused by filtering and averaging of the pressure signal with the goal of achieving a non-oscillating display of mean pressure.No device issue could be confirmed.Livanova (b)(4) will continue to monitor for trends related to this type of issue.Evaluated on site by livanova technician.

• Brand Name: STOCKERT S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich ; GM
• 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: 4379363
• MDR Text Key: 5239034
• Report Number: 1718850-2014-00474
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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