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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 08/26/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in madrid, spain.Livanova learned that the involved pump started to run at around 10:25 am and after two or three minutes it was stopped, without any alarm.Then, the customer tried to give flow and since it did not respond, hand-crank was used to give it manually.No further issues occurred.Involved roller pump was turned on again and the surgery was completed successfully.In addition, it was learned that neither active level sensor nor any other roller pump control system were set by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a s5 roller pump stopped during procedure without raising any alarm.There was no patient injury.

Manufacturer Narrative

The equipment was inspected by an authorized service technician and no deviation in the hardware and no reason for the stop was found.Roller pump cover and magnet were found to work properly.Investigation on log files confirmed the hand crank but it is still 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 confirming that the user started performing hand crank at 10:27.Moreover it was found that at 10:26 a "cover open" alarm stopped the pump and right after that 4 events of switching off and on the alarm audio are stored, suggesting that the user heard the alarm while re-opening the cover to perform hand crank.At 10:28 a notif_clear is stored, indicating that the user acknowledged the error and clear the notification.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2018.Based on all information collected, it cannot be excluded that the cover was not properly closed when starting the procedure or that a temporary electrical failure of the sensor that monitors whether the cover is closed occurred and was fixed by the technician during the equipment inspection.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17860554
• MDR Text Key: 324795263
• Report Number: 9611109-2023-00480
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)181217
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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