MAUDE Adverse Event Report: LIVANOVA DEUTCHSLAND SORIN S3 CONSOLE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 43-50-00

Device Problems Failure to Auto Stop (2938); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s3 console.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 report that the low level detection for the sorin s3 console did not work correctly during a procedure.The system did not stop the arterial pump when the oxygenator was empty.There was no report of patient injury.A sorin group field service representative contacted the customer and found that the level sensor had been discarded.No product will be returned for evaluation.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Device discarded by customer.

Event Description

Sorin group (b)(4) received a report that the low level detection for the sorin s3 console did not work correctly during a procedure.The system did not stop the arterial pump when the oxygenator was empty.There was no report of patient injury.

Manufacturer Narrative

This is a follow up to initial mdr submitted.Investigation is complete.Correction has been made to previously noted as no information, has now been updated to malfunction.Mfr site has been updated to reflect name change from sorin group to livanova.Device was scrapped by field service rep.

• Brand Name: SORIN S3 CONSOLE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHSLAND; lindberghstr 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan caesar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5686777
• MDR Text Key: 46164506
• Report Number: 9611109-2016-00345
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K950990
• 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: 10/27/2017

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: 43-50-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/27/2016
• Supplement Dates Manufacturer Received: 04/27/2016
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2002
• 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 Age: 7 MO