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

Model Number	10-85-00
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report about an internal error occurred in the myocardial protection pumps (3a, 3b), and the error number was not stored.The device was turned the off and on, but it keeps happening again, and the pump head is moving very awkwardly.There is no report of patient impact.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova initiated an investigation.Livanova received the pump and read out the log file.No errors have been observed.There are no problems with visual checks of the inside of the equipment.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: the affected part was returned to livanova japan for a detailed investigation and repair.Upon testing, no issue has been reproduced, pump was found working and no internal damage was found that could have caused reported issue.Taking into account the behavior described by customer, technician replaced the motor control boards (hms) for both pump heads due to suspect temporary electrical failure of them.After replacing the parts, functional tests were carried out and passed positively before returning unit to service.A device service history review has been performed and identified that the unit was manufactured in 2016 and no other similar event has been reported, neither concerning trend has been identified.The read-out (real-time device parameters and setting recording file) of the roller pump was gathered and analyzed.Log files analysis confirmed several occurrences of both motor control failure (error code 442) and runaway faults.Error 442 (text string "no_pulse_block") indicates detection of speed set value different to actual value, prevent the system to be properly controlled and can be related to: - over-occlusion; - wrong tubing; - rotor blocked by foreign object; - rotor tight rotating due to defective bearing.Runaway fault (error code 449, text string "runaway_peak") indicates that the pump run too fast and it usually occurs when: - pump is hand cranked without switching it off; - hardware reset of pump (off/on); - defective motor control board/hall sensor in the pump head.Taking into account that the reported anomalous pumping behavior of the pump and the outcome of technical inspection, it can be excluded a motor hardware defect, while it is reasonable to assume that defective motor control boards caused the pumps to run abnormally, with a possible contribution of occlusion not properly set.

• Brand Name: S5 DOUBLE ROLLER PUMP 85
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich CO 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20809263
• Report Number: 9611109-2024-00575
• Device Sequence Number: 13075170
• Product Code: DTQ
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)160610
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071318
• 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): 01/15/2025

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 Model Number: 10-85-00
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown