MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	28-95-80
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 control panel mrp 150/85.The incident occurred in hong kong.The serial read out (real time device parameters and setting recording file) of the pumps were collected.Neither the affected pump nor any other pump showed any malfunction stored in the logs file.Based on the logs analysis, an issue affecting all the hlm system (emc disturbances) can ruled out.The mast roller pump and its panel have been requested back to manufacturer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that, during a bypass, when main pump (mast rp150) reached full flow, the pump stopped and the s5 control panel mrp 150/85 control panel screen went black.The user tried to switch off and on the mast pump control panel and it didn't restart.The other pumps were functioning and the display panel was fine.The user elected to replace the whole s5 unit to another standby unit.There is no report of any patient injury.Later when they restarted the s5 system, the mast roller pump turns on again.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The real time device parameter readout analysis excluded any common failure affecting all pumps or the overall hlm system (e.G.Emc disturbances) and excluded any pumps malfunction.The mast roller pump and its control panel were returned to livanova for a dedicated investigation.Visual inspection found external signs of oxidation with no functional impact were detected on the pole and the pump.No damage to the pump and control panel cables was observed.The system composed of the pump and its control panel was run intensively at different rpm and was prolonged switched on.No deviation was detected and the system functionality test was positively passed.The functionality test was also conducted simulating high stress conditions by means of a climate chamber set at 40 °c for three hours.No anomalies have been detected and the system functionality stress test was positively passed.The control panel was opened to have access to its electronics.The connection to the power supply and the connection to can bus did not show any deviations.The electronics of the circuit board had no signs of burnt, oxidized, or faulty components.The control panel on/off switch was disassembled from the housing and opened, the internal components (the ball and the metallic clip) did not show any signs of wearing.The root cause the issue can be related to an accidental error by the user who: inadvertently hit the on/off switch button on the back of control panel while moving, or inadvertently didn¿t properly connect the push-pull power cable from the control panel to the s5 e/p pack that disconnected during use (e.G.Hit, movement, vibration).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.Since it was excluded a device malfunction and therefore the issue was solely caused by user error no patient impact (no death or serious injury), present event has been re-assessed as not reportable.

• Brand Name: S5 CONTROL PANEL MRP 150/85
• 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
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18433428
• Report Number: 9611109-2024-00004
• Device Sequence Number: 17900790
• Product Code: DWB
• UDI-Device Identifier: 04033817900818
• UDI-Public: (01)04033817900818(11)190529
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 28-95-80
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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