MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problems Pumping Stopped (1503); Pumping Problem (3016)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Livanova (b)(4) received a report that, during a procedure, a s5 master roller pump stopped due to a high pressure alarm triggered by the pressure transducer linked to the pump.After having restored the pressure on the circuit, the pump did not re-start.There was no patient injury.

Manufacturer Narrative

Patient information were not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(4).Livanova learned that the customer has two (2) s5 systems and after the event he used only the second one, segregating the first one claimed.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.A simulation of the event occurred was performed by increasing the pressure and linked s5 master roller pump to a pressure simulator: pump speed decreased until its stop.When the pressure decreased instead, the pump automatically accelerated the speed and resumed the initial flow setting.Simulation was done several times and no issue occurred.Investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

The serial read-out of the pump (real time device parameters and setting recording file) was analyzed and confirmed that on the date of the event the reported alarm was stored in the pump microcontroller.In particular: - several pressure alarms were stored on (b)(6) 2022 (press_stop 0 1), the first at 11.14, and the pump stopped correctly.The last pressure alarm was at 12.34 followed by the pump stopping; - after that (after two minutes: 12.36), the customer rotated the knob to bring the pump to zero (shenc_is_zero 0), and it stopped; - three minutes after this event, the customer opened the cover, the pump stopped and the hand-crank was potentially started at 12.40.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2017.Based on the serial read-out analysis, on the non-reproducibility of the event by the livanova field service representative who, simulating the issue, noticed the pump correctly resume its function once the pressure value has been re-established, and also based on that the customer has experienced out-of-threshold pressure events for about 1h (over 40 occurrences of press_stop 0 1), it cannot be ruled out that the most likely root cause could be traced back to a pressure condition off-threshold which never returned below the threshold and consequently did not allow the pump to restart safely according to its design.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 150 (S5 RP150)
• 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: 15985128
• MDR Text Key: 305843397
• Report Number: 9611109-2022-00672
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)170426
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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