MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP 150 (S5 RP150); 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 10/09/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump turned off during procedure.The complained pump is not an arterial pump.Later, the pump restarted on its own.There is no report of any patient injury.

Manufacturer Narrative

Patient information were not provided.Livanova deutschland manufactures the s5 double head pump.The incident occurred in austria.The error could not be verified by the biomedical engineers in the hospital who did the repair.The hkr (computer board) was replaced.The readout of the hkr (computer board) from the latest case was provided to livanova.The log only goes back to later than the event date.According to follow up information, there was no alarm or error code.The pump was completely deactivated as if power was switched off.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

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2008.Most likely root cause of the reported issue can be traced back to a defective computer board (hkr) due to the wearing of its electronics.

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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15948567
• MDR Text Key: 306982051
• Report Number: 9611109-2022-00660
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1