MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SCP WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 48-40-00

Device Problem Intermittent Communication Failure (4038)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that a s5 console displayed error erc timout (e117) in the scp with all display freeze during a procedure.There was no report of any patient injury.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the scp with tubing clamp.The incident occurred in france.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: e117 signals a timeout of the erc and can be caused by: contact errors on plug-in connectors, defective main connector cable, trip of the circuit breaker of the tubing clamp, power supply issue that prevent the connection with scp system.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Can internal and external communication boards were replaced without solving the issue.Therefore, the whole faulty e/p (electronics and power) pack was replaced with a loan one and the issue was then fixed.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2014.Based on technical intervention, most likely root cause of the event could be traced back to a failure of an internal component of the e/p pack, likely due to the wearing of the unit that prevented the erc to be properly power supplied and therefore losing connection with the scp system.Failure of electronic components can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro sub-components.

Event Description

See initial report.

• Brand Name: SCP WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18064749
• MDR Text Key: 327273122
• Report Number: 9611109-2023-00588
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032213
• 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: 11/03/2023

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: 48-40-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2014
• 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