MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 ERC TUBING CLAMP/500MM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Catalog Number 60-05-60

Device Problem Difficult to Open or Close (2921)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in united states.Livanova initiated 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 that flow dropped with electronic remote clamp activated by itself during a procedure there is no report of any patient injury.

Manufacturer Narrative

No additional information has been provided by customer and no request of service activity has been requested.Consequently, it can be assumed that the issue was a one-off event never reoccurred.Complaints database analysis revealed no similar event since unit installation in 2019.Considering the level of information provided, a specific root cause cannot be determined.However, based on similar events reported by other customers the most likely root cause of the event are the following: (i) defective internal board; (ii) faulty communication between the mentioned erc and the related s5 console and/or (iii) user perception ( erc clamp correctly closed following an alarm condition).The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: SRD S5 ERC TUBING CLAMP/500MM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17170967
• MDR Text Key: 317595817
• Report Number: 9611109-2023-00278
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901051
• UDI-Public: 010403381790105111190527
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/29/2023

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 Catalogue Number: 60-05-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2019
• 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