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

Model Number 10-80-00

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected device was requested back to the manufacturer site.Investigation results confirmed the reported error message and bugs in the microcontroller were identified.The most likely root cause is that the pump has been updated multiple times without deleting the memory.Indeed, after the memory clear, the error was no longer reproducible.The motor control board will be replaced as precaution.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a s5 roller pump displayed a motor control error message during priming.There was no patient involvement.

Manufacturer Narrative

H.10: in the initial report it was stated that the motor control board would have been replaced.The correct part which has been replaced is the processor board.The device has been returned back into service.

Event Description

See initial report.

Manufacturer Narrative

H.10: from service report review it was found that previously to this event a technical intervention was carried out for firmware update to r267.Based on all information available it cannot be ruled out that potential root causes of the event can be the following: update of the pump firmware without the techncian deleting internal memory first which can trigger possible sw exceptions.Loss of connection to the processor board.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9755084
• MDR Text Key: 197108477
• Report Number: 9611109-2020-00138
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1