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

Model Number 10-60-00

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Device has not been returned to sorin group (b)(4).Sorin group (b)(4) manufactures the s3 roller pump 150.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the control knob on the s3 roller pump became unresponsive during priming.No error codes were present.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the issue and identified a damaged speed potentiometer.The speed potentiometer was replaced and the issue could no longer be reproduced.A functional verification was peroformed and no further issues were noted.The customer is retaining the replaced speed potentiometer.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Customer retains replaced device.

Event Description

Sorin group (b)(4) received a report that the control knob on the s3 roller pump became unresponsive during priming.No error codes were present.There was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s3 roller pump 150.The incident occurred in (b)(6).This medwatch report is filed on behalf of livanova (b)(4).A review of the dhr did not identify any manufacturing deviations or non-conformities relevant to the reported issue.No additional information has been received.If additional information is received, it will be evaluated for reportability as required.The result of the investigation does not provide any evidence to determine a root cause for the reported event.Livanova has determined that a capa is not required, as there was no patient harm reported.Livanova will continue to monitor this issue for trends.

• 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: 5693562
• MDR Text Key: 46360860
• Report Number: 9611109-2016-00308
• 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,Followup
• Report Date: 12/14/2017

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: 10-60-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2006
• 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