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

Catalog Number	60-05-60
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
See intial report.

• Brand Name: SRD S5 ERC TUBING CLAMP/500MM
• Common Device Name: 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
• Report Number: 9611109-2023-00278
• Device Sequence Number: 17790522
• Product Code: DWA
• UDI-Device Identifier: 04033817901051
• UDI-Public: 010403381790105111190527
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 60-05-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown