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

Model Number 10-88-00

Device Problems Failure to Pump (1502); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.A serial readout was performed and sent to livanova (b)(4).The technician also decided to replace the motor endstage board and motor control board as a precaution.Subsequent functional verification testing was completed without issue and the unit was returned to service.The serial readout could not be analyzed by livanova (b)(4) due to an error during extraction of the data, as well as the old hardware in the device at the time of the event.Both boards have been requested for return to livanova (b)(4) for further evaluation.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.Device not returned.

Event Description

Livanova (b)(4) received a report that an s5 mast roller pump did not turn when the flow was adjusted during a procedure.However, the user reported that the displayed flow value did respond to the changes.The user attempted to override but was unable to get the pump head to turn.The device was hand-cranked while connections were checked and the device was restarted.Following the restart, the pump started functioning as expected.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).Both boards of the s5 mast roller pump that were replaced by the livanova field service representative were returned to livanova (b)(4) for further investigation.During investigation, the reported issue could not be reproduced.No deviations were identified on the motor end stage and motor control circuit boards.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• 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: 6970577
• MDR Text Key: 90753373
• Report Number: 9611109-2017-00854
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2007
• 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