MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MAST ROLLER PUMP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-80

Device Problem Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 control panel mrp 150/85.The incident occurred in (b)(6).Through follow-up communication livanova learned that the patient was perfused by hand with the hand crank after a standstill for 10 seconds and that no medications were required.In addition, it was reported that the control panel screen appeared to be frozen.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The device was found to be working properly.The motor control board was replaced as potentially involved component.Subsequent functional verification testing was completed without further issues and the unit was returned to service.No further similar event reported after the repair.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a s5 mast roller pump gave a motor control failure error message during a procedure and did not respond to the speed control knob.The user hand-cranked the pump to continue patient perfusion.The pump was replaced with another to complete the procedure.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: after replacement of the motor control board no further complaints on this specific device have been received.The most likely root cause is a failure of components on the motor control board.

• Brand Name: S5 CONTROL PANEL MAST ROLLER PUMP 150/85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• MDR Report Key: 12318522
• MDR Text Key: 266402125
• Report Number: 9611109-2021-00454
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-95-80
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1