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

Model Number 48-40-00

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.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 the flow sensor of the sorin s5 system suddenly showed a drop in flow when the rpm was maxed during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.The customer reported to the service representative that no unusual resistance was found in the circuit.The service representative tested the unit and was unable to reproduce the reported issue.The flow sensor was replaced as a precaution and a functional verification was performed.No further issues were reported and the unit was returned to service.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 flow sensor of the sorin s5 system suddenly showed a drop in flow when the rpm was maxed during a procedure.There was no report of patient injury.

• 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): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w 65th.way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5985100
• MDR Text Key: 55874470
• Report Number: 9611109-2016-00675
• 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
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• 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?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2009
• 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