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

Model Number 10-80-00

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

Livanova received report that of a s5 roller pump shut down on its own during set up.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in jefferson, louisiana.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: the involved roller pump was manufactured in 2014 and according to the analysis of the complaints database no further similar events related to this unit have been reported in the past.A livanova field service technician was dispatched to the customer facility.The reported malfunction could not be reproduced.However, the touchscreen was found not functional (it did not respond to touch input).Touchscreen function could be temporary restored by powering off and back on, however, the touchscreen failed after a few minutes of operation.Taking into account the collected information, it cannot be ruled out that a defective processor board was the cause of both issues (pump shut down and the touchscreen malfunction).Based on the above, the most likely root cause of the reported event is traced back to a defective processor board.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15210081
• MDR Text Key: 298244877
• Report Number: 9611109-2022-00419
• Device Sequence Number: 1
• Product Code: DWB
• 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
• Report Date: 08/11/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/14/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2014
• 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