MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SCP CONTROL PANEL W/FAST CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-50

Device Problems Infusion or Flow Problem (2964); Noise, Audible (3273)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

H10: livanova deutschland manufactures the s5 system.The incident occurred in united states.A livanova intiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report some wrong issue with flow on drive of an s5 console during a procedure.Also of fan was making noise.There was no patient injury.

Manufacturer Narrative

H.10: through follow-up communication, livanova learned the involved centrifugal pump system with tubing clamp (scp) which was used during the surgery.Model/serial numbers have been updated to the dedicated d.4 section.In addition, it was learned that technical service requested has been canceled and therefore no livanova technical intervention is foreseen at the moment.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

A livanova field service engeneer contacted the biomed at the hospital and it was clarified the complained issue was a noise from the fan inside the control panel.This unit has reached its ¿end of life¿ so repairs cannot be completed.This is the reason customer needed to cancel the repair and the device was not troubleshooted.The event has been reassessed as not reportable since no device malfunction has occurred and the claimed noise has unlikely possibility to cause any patient injury.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: SCP CONTROL PANEL W/FAST CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17002169
• MDR Text Key: 315928348
• Report Number: 9611109-2023-00240
• Device Sequence Number: 1
• Product Code: DTQ
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-50
• Device Catalogue Number: 60-02-50
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2009
• 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