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

Model Number 10-80-00

Device Problem Pumping Problem (3016)

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

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump, used as cardioplegia pump, gave two error messages related to runaway fault (the pump ran too fast; set value different to actual value) and to motor control failure.The issue occurred during priming.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in cleveland, ohio.Following first error message related to runaway fault, the cardioplegia circuit over-pressurized.Then, involved pump was turned off and back on by the customer and motor control failure error message appeared.After this, pump was replaced with a back up one.Through follow-up communication livanova learned that the repair of the affected pump will be carried out by customer biomedical engineer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : repair will be done by customer biomedical engineer.

Event Description

See initial report.

Manufacturer Narrative

H10: based on investigation results of similar complaints, most likely the root cause of the reported event can be traced back to defective motor control (hms) board and/or motor power amplifier (hmf) 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17323001
• MDR Text Key: 319026537
• Report Number: 9611109-2023-00328
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2010
• 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