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 Insufficient Information (4580)

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6), italy.The serial read-out of the involved pump (real time device parameters and setting recording file) was analyzed and no "watchdog" was stored on the date of the event ((b)(6) 2023), therefore there was no interferences from high frequency devices which may have caused the pump to stop.In addition, through follow-up communication with livanova field service representative, it was confirmed that the involved pump stopped and no alarms were observed by the customer.However, three yellow triangles have appeared on the pump screen simultaneously and corresponding to the following fields: flow display: displays the current flow rate in liters per minute [l/min]; pump speed: displays the current pump speed in revolutions per minute [rpm]; display flow display.Consequently, even by turning the knob, no pump rpm increase was possible.The perfusionist performed the hand-crank and then replaced the device to continue the procedure.No hardware malfunction was confirmed during unit inspection performed by livanova field service representative at the customer site.The involved pump worked properly.Customer confirmed that the patient was conscious after the surgery and later died due to his critical conditions.In addition, livanova performed a medical assessment of the case through the involvement of qualified personnel to make a medical judgment.The outcome was that with hand-crank procedure done by the customer, there was no risk for the patient.Moreover, no interruption on the perfusion occurred, confirming that the patient died is not related to the device usage.Lastly, the device replacement has been performed with no issue during the hand-crank and the procedure continued with no perfusion interruption.Based on the considerations above, only a device malfunction occurred and the patient death was related to his clinical critical conditions.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 stopped during procedure.The patient was conscious after the surgery and later died due to his clinical critical conditions.

Manufacturer Narrative

The affected part was returned to livanova deutschland for a detailed investigation.The technician could not reproduce the reported issue.The pump ran continuously for four (4) days without any problems.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.

Manufacturer Narrative

Unit was inspected by tssi and no error was confirmed.Device was cleaned, disinfected and ran continuously from thursday 13.07 to monday 17.07 without any problems or errors found in the can.Pump was sent back to customer.The serial read-outs (real time device parameters and setting recording files) were provided by fse and analyzed.Results of analysis confirmed hand cranking on the roller pump sn 10e17342 from 10:54.At 10:53 a level alarm was recorded and correctly stopped the pump.By design, the roller pump is stopped by level monitoring if the level drops to the stop limit.The alarm can be overridden by the user from the system panel.Touchscreen resistance was high.Based on the information above, it cannot be ruled out that the pump stopped due to an unresolved level condition monitored through the level sensor.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17297912
• MDR Text Key: 319026622
• Report Number: 9611109-2023-00321
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)181030
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/21/2023

1 Device was Involved in the Event

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/17/2023; 11/28/2023
• Supplement Dates FDA Received: 08/03/2023; 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death