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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump, used as arterial pump, stopped during procedure.Hand crank was used by the customer to complete the surgery.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in new delhi, india.Through follow-up communication with the customer livanova learned that the event occurred on (b)(6) 2023 at 11:10 am; it is not sure that an error message was displayed on s5 system following pump stop.The serial read-out of the pump (real time device parameters and setting recording file) was analyzed and confirmed that on the date of the event from 14:03 hand cranking was performed.At 13:15 an alarm that rotations per minute (rpm) went to zero is stored.Since it is not preceded by the manual turning of the encoder to zero rpm, it is reasonable to assume that an event stopped the pump.No specific error was found in the log files.Multiple pressure stops were found to be listed in the read-out.By design, the roller pump is stopped by pressure monitoring if the measured value exceeds the limit.Alarms can be overridden by the user from the s5 system panel.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The involved pump ran for 5-6 hours continuously two days without any error message and without any abnormality.It was also tested at different rotations per minute (rpm) and at pressure-controlled mode with no deviation found.Based on all the information available, it cannot be ruled out that the reported event is not an irreversible malfunction and that the pump stopped due to an unresolved high pressure condition monitored through the pressure module.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17297833
• MDR Text Key: 318885477
• Report Number: 9611109-2023-00313
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)151110
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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