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 Low Blood Pressure/ Hypotension (1914)

Event Date 08/31/2022

Event Type  malfunction  

Event Description

Livanova received report that the cardiopulmonary bypass was running for about 155 minutes when the pressure alarmed and the main pump stopped running and could not be restarted.Thus, hand-crank was performed for 4-5 minutes until the main pump was replaced.Reportedly, the whole process took about 7-8 minutes and during this time the patient's blood pressure was low which did not cause a greater impact.There was no patient injury.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in shenzhen, china.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

Manufacturer Narrative

Livanova received report that, during a cardiopulmonary bypass, pressure alarmed was triggered, the main pump stopped running and could not be restarted.Medical team elected to hand-crank the patient for 4-5 minutes until the main pump was replaced.The whole process took about 7-8 minutes and during this time the patient's blood pressure low.There was no patient injury.As part of the investigation, the electronic record of the perfusion (e.G.Connect record) was requested.However, no recording device was in use during the procedure.The pump sheet was requested as well and not provided.A distributor engineer was dispatched to the customer facility.The pump was tested and was found working according to specification: no deviations were identified.Through follow up communication livanova learned that: the pressure threshold for alarm/stop was set to 300mmhg, and the pressure threshold for warning/control was set to 270mmhg.The pump is currently in use by the customer and no further issues had occurred since the date of this report.No additional info / data are available due to the covid-19 pandemic situation in china.The involved roller pump was manufactured in 2018 and according to the analysis of the livanova complaints database, no further event has been reported.Based on the above and taking into account that no components were replaced and the unit is still properly in use at the customer site, hardware malfunction with the pump can be ruled out as cause of the event.It is reasonable that that pump did not restart due to a persistent pressure alarm situation.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Manufacturer Narrative

Through follow-up communication livanova learned model and serial numbers of the affected device.Information have been added to the dedicated d.4 section as well as udi code and manufacturing date of device has been added accordingly to h.4 section.H.10: the pump was tested by a livanova representative and was found to be working within specifications.Through follow up communication livanova learned that the pressure threshold for alarm/stop was set to 300mmhg, and the pressure threshold for warning/control was set to 270mmhg.

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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15585431
• MDR Text Key: 301922260
• Report Number: 9611109-2022-00512
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)180628
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 12/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2018
• 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