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

Model Number 48-40-00

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 11/04/2015

Event Type  Death  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).Sorin group received a report that a patient died during a procedure involving the sorin s5 system.At this time, sorin group has not received additional information regarding the event.Follow-up communication with the biomedical engineer has not resulted in any new information as to what occurred and the involvement, if any, of the sorin s5 system or any other manufacturer's equipment or disposables that may have been used in the procedure.The subject unit has been pulled from use.A supplemental report will be submitted if and when any new information becomes available.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that a patient died during a procedure involving the sorin s5 system.Follow-up communication with the biomedical engineer has not resulted in any new information as to what occurred and the involvement, if any, of the sorin s5 system or any other manufacturer's equipment or disposables that may have been used in the procedure.

Manufacturer Narrative

(b)(6) female.On (b)(6) 2016, sorin group received a user medwatch report ((b)(4)) stating that the perfusionist primed the line during a procedure at the request of the surgeon to expel air.The perfusionist was unable to restore flow from the sorin s5 system.The surgeon began open heart compressions, however the patient expired.Device available for evaluation? yes.(b)(6).Risk/data specialist.Initial reporter also sent the report to fda? yes (b)(4).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).On (b)(6) 2016, sorin group received a user medwatch report ((b)(4)) stating that the perfusionist primed the line during a procedure at the request of the surgeon to expel air.The perfusionist was unable to restore flow from the sorin s5 system.The surgeon began open heart compressions, however the patient expired.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

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 received a report that a patient died during a procedure involving the sorin s5 system.On february 26, 2016, sorin group received a user medwatch report ((b)(4)) stating that the perfusionist primed the line during a procedure at the request of the surgeon to expel air.The perfusionist was unable to restore flow from the sorin s5 system.The surgeon began open heart compressions, however the patient expired.A sorin group field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.However, it was discovered that the facility was using a non-sorin centrifugal adapter plate and disposable, contrary to the current instructions for use.A preventative maintenance was carried out.The system was found to be working according to specification and was released to the customer.The previous preventative maintenance was performed by a third party service organization.As the issue could not be duplicated, an exact root cause could not be determined and no corrective actions were identified.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Evaluated on site by sorin service rep.

• Brand Name: SORIN S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, D 809 39; GM D 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: 5251545
• MDR Text Key: 32180334
• Report Number: 9611109-2015-00563
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• 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
• Patient Outcome(s): Death