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

Model Number 10-80-00Z

Device Problem Unexpected Shutdown (4019)

Patient Problems Brain Injury (2219); Loss of consciousness (2418); Cerebral Edema (4403)

Event Date 09/03/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Through follow-up communication livanova learned that the patient is still in the icu and that a loaner pump has been provided in replacement of the claimed one.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that during cpb (on min.160) main arterial pump stopped (full shutdown); customer tried to switch on switch off pump couple time without success and hand crank was performed.The patient condition is extremely severe, unconsciousness, extensive ischemic brain damage, cerebral edema, triplegia.

Manufacturer Narrative

Livanova received a report stating that during cpb procedure, main arterial pump stopped.Customer tried to switch off and on again pump a couple time without success and hand crank was performed.The patient condition is severe.No additional information on the patient's status was provided due to data protection.The review of the read-out highlighted and confirmed that errors related to the motor control failure occurred on event date.Additionally, the impacted pump returned for further investigation and tsi at the manufacturing site.Error - fault in motor controller (e431)- always appeared when the pump was switched on during internal tests.Thus, the motor control failure has been reproduced.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The pump was manufactured in june 2021 and the analysis of the complaints on this pump has highlighted that no other events have been recorded before 3 september 2022.Thus, the event is isolated.Most likely the power supply of the impacted hms board is turned off, the pump does not start the drive.It cannot be ruled out that a component of the board such as the dc/dc converter (power supply) did not work and this led to the errors.Based on livanova medical team, the patient outcome is related to the patient status before the procedure.There is no relationship between patient outcome and device failure.There is no concerning trend for this kind of failure.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

Manufacturer Narrative

The serial read out of the pump was provided and analysis is ongoing.Through follow-up communication with the perfusionist livanova learned that: during priming of oxygenator and pre-setup of s5 hlm it was no error message displayed.In beginning of cpb procedure, right after cannulation, tehre was a motor control failure error message.Perfusionist restarted the pump and cleared the alarm and the pump was functioning correctly.On the end of cpb procedure the pump stopped completely and two motor control.Failure error messages were displayed attempt to restart the pump was performed a couple of times with no improvement of the issue.Hand crank was performed.Customer checked pump functions a couple of times in next day¿s (without patient connected) and in the beginning pump worked properly, but after approximately 20 minutes - 1 hour pump stopped.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduced the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10.The pump shows error code 442 which means that either the current measurement on hmf board or the resolver is faulty (or the motor is blocked).In this case, the output signals from the resolver are not correct and the hms and hmf boards are conforming.Pump will be repaired.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: the affected unit was returned to livanova deutschland for a detailed investigation.The investigator could reproduce the reported issue.In order to fix it, pump head (motor) rp 150 and motor control board were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 15518689
• MDR Text Key: 301469925
• Report Number: 9611109-2022-00499
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)210625
• Combination Product (y/n): N
• Reporter Country Code: KZ
• 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,Followup,Followup,Followup,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• 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
• Patient Outcome(s): Other; Disability
• Patient Age: 77 YR
• Patient Sex: Female