MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 DOUBLE ROLLER PUMP 85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-85-00Z
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland has received a report that the roller pump 85 twin pumps went in a runaway state.Pumps displayed error code 1a and error indicating that pump spinning in the opposite direction.The issues occurred during a procedure.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the roller pumps.The incident occurred in united states.Custome has been provided of another pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
A device service history review has been performed and identified that the unit was manufactured in 2023 and review of the dhr could not identify any deviations or nonconformities relevant to the issue.Field service on site replaced the pump with another one.Complained roller pump was sent to manufacturer for investigation and repair.Upon inspection at manufacturing site the pump started to turn on and off randomly.This issue may be caused by a defective board.As preventive measure it has been recommended to replace also the motor driver and control boards for both pumps.No repair request has currently been received from customer, therefore no service activity on the pump has been performed yet.Log files were gathered by technical team and provided to be analyzed.Several runaway errors and wrong direction code were confirmed in the extracted log file.In addition a can timeout with subsequent watchdog reset and disconnection of the motor was stored on the date of event.Can timeout occurs when a safety feature of the pump has failed and therefore the pump no longer allows the system to monitor it properly.Based on the technical inspection of the pump and the result of log file, the most likely root cause of the reported issue has been traced back to an early failure of the electronic board.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro subcomponents.However, 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.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18038950
• Report Number: 9611109-2023-00576
• Device Sequence Number: 8398225
• Product Code: DTQ
• UDI-Device Identifier: 04033817902737
• UDI-Public: (01)04033817902737(11)230605
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: 10-85-00Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown