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

Model Number 48-50-00

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).The serial read-out of all roller pumps in use on the s5 system have been analyzed and revealed the simultaneous occurrence of watchdog events pointing to electromagnetic interferences as root cause of the event.Through follow-up communication livanova learned that a fibrillator was used in the operating room.

Event Description

Livanova (b)(4) received a report that a motor control failure error messages were displayed on the roller pumps in use on a s5 system during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility and installed an equipotenzial cable with blocking ferrite in order to solve the electromagnetic interferences problem.

Event Description

See initial report.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 10948112
• MDR Text Key: 219889101
• Report Number: 9611109-2020-00669
• Device Sequence Number: 1
• Product Code: DTQ
• 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
• Report Date: 11/30/2020

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: 48-50-00
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1