MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); 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 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

A.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in united states.A livanova field service engineer was dispatched to the customer.I checked this system today and could not duplicate the problem.Checked all mt connections inside the pump and did download serial read out (real time device parameters and setting recording file) of the pump was collected as per follow up with the customer: the customer uses roller pump for ecmo.The pump was put on the patient (b)(6) 2023 and the problem happened (b)(6) 2023.Pump stopped while on patient and did not alarm.Had an error message but they are not sure what it said.I was told two different errors.First control panel error, second it was a motor control error.Pump was on for 2.5 days that stopped they reset the power to the system and keep pump on patient for 13 days until they had to change the tubing so they just swapped out systems.According to device ifu, hlm s5 system is not validated for prolonged use, as ecmo.To be confirmed if this off-label use could lead to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 roller pump 150 stopped during a procedure and did not sound the alarm.Error message related to control board problem was displayed on the display (exact wording could not be remembered).Medical team turned the sistem off an on and the problem went away.There is no report of any patient injury.

Event Description

See initial report.

Manufacturer Narrative

Serial read out (real time device parameters and setting recording file) of the pump was collected and investigated.In the section for fail and stops of the pump, six events were stored and confirmed the "motor control error" reported on the date of event ((b)(6) 2023 at around 7:40).The error that was displayed was permanent_current_offset: mean value read incorrectly, error cannot be deleted; current measurement/setpoint values differ (e429).This is a fault in motor controller and, when this error is displayed, the flat ribbon cable and hms board need to be replaced.Data stored on the log files for procedure events ends on (b)(6) 2023, it is likely that previous events have been deleted or overwritten.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: based on the information collected, livanova field service technician returned on site and replaced the motor control board (hms) as a troubleshooting indicated in the device service manual for this type of error code.The unit returned to service.A device service history review has been performed and identified that the unit was manufactured in 2020 and no other similar event has been reported, neither concerning trend has been identified.It cannot be ruled out that the most likely root cause of the reported event was a false contact on the motor control board (hms) that got re-established after the user reboot.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• 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: 17964865
• MDR Text Key: 326030186
• Report Number: 9611109-2023-00542
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900382
• UDI-Public: 010403381790038211200224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024
• 2 Devices were Involved in the Event: 1 2

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: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 02/05/2024; 02/07/2024
• Supplement Dates FDA Received: 02/05/2024; 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• 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