MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-60-00

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s3 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication, livanova (b)(4) was informed that the customer does not plan to repair the s3 roller pump.The customer plans to discard the s3 device and purchase a new s5 unit.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Customer does not want repair.

Event Description

Livanova (b)(4) received a report that a burning smell was noted coming from the s3 roller pump during a procedure.There was no report of patient injury.

• Brand Name: S3 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• 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: 6694794
• MDR Text Key: 79521700
• Report Number: 9611109-2017-00527
• Device Sequence Number: 1
• Product Code: DWB
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-60-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/1997
• 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