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

Model Number 28-95-85

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a error message occurred during priming on a s5 mast roller pump.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in (b)(6).A replacement device will be provided to the customer.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10 only 1 roller pump received and the serial read out does not highlight any malfunction.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

Further analysis of serial read-out confirmed the reported event.An error was stored in the micro-controller on the day of the event indicating that there was no signal from the main panel.Based on the investigation performed for similar cases, this error code can be caused by a malfunction of the processor board located in the mast control panel.Moreover, several disturbances on the bus were registered.The can_timeout message stored in the micro-controller indicates an interrupted communication of the internal can between the processor board (located in the pump control panel) and the motor controller board (located in the pump module).However, taking into account the presence of can disturbances and reset events stored in the read-out, it cannot be ruled out that interference of high frequencies device in use next to the heart lung machine could have contributed to the reported event.In conclusion, based on the analysis of the serial read-out, the most likely root causes of roller pump stop are: - hardware malfunctions of internal electronic components and, more in specific, of the processor board.- disturbances of high frequencies external devices used next to the s5 machine.Since it could not be possible to collect the serial read-outs of all the other roller pumps in use during the same procedure, the hypothesis of high frequencies disturbances cannot be confirmed.The mast control panel will undergone a technical safety inspection at the manufacturer site and as per equipment maintenance interventions prevention, the processor board will be replaced.

Event Description

See initial report.

Manufacturer Narrative

H.10: the processor board of the affected device was replaced as well as touchscreen.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

• Brand Name: S5 CONTROL PANEL MRP 85
• 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: 12953763
• MDR Text Key: 284630098
• Report Number: 9611109-2021-00694
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/29/2021

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: 28-95-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/02/2021; 01/07/2022; 07/03/2022
• Supplement Dates FDA Received: 12/29/2021; 02/01/2022; 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2011
• 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