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

Model Number 43-50-00

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Patient information was not provided.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 received a report that the sorin s3 console became stuck in cardioplegia mode during a procedure.The device could not be programmed and would not respond.There was no report of patient injury.Through follow-up communication with the perfusionist, sorin group (b)(4) has been informed that the issue was the result of the user forgetting to plug something in.The customer has canceled the request for service and no further investigation is necessary, as the issue was caused by user error.A review of the dhr was unable to identify any deviations or non-conformities relevant to the issue.Sorin rep spoke with user; user error.

Event Description

Sorin group (b)(4) received a report that the sorin s3 console became stuck in cardioplegia mode during a procedure.The device could not be programmed and would not respond.There was no report of patient injury.

• Brand Name: SORIN S3 CONSOLE
• 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: 5462205
• MDR Text Key: 39084955
• Report Number: 9611109-2016-00050
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/26/2016

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2004
• 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