MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 MAST ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-88-00

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to two defective boards.The technician replaced the motor control and motor end stage board to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The defective boards were returned to livanova (b)(4) for further investigation.During the evaluation of the boards the reported failure could be confirmed.It was possible to trace the failure back to a software issue on the motor control board.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

Livanova (b)(4) received a report that a s5 mast roller pump did not turn on during priming.There was no patient involvement.

• Brand Name: S5 MAST 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: 7056652
• MDR Text Key: 93170308
• Report Number: 9611109-2017-00918
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062396
• 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: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-88-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2006
• 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