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

Model Number 60-05-60

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp / 620mm.The incident occurred in usa.According to livanova field service, the erc lost the connection with the e/p pack.And was defective or it was disabled by perfusionist.Livanova field service could not duplicate error message but did get a "no tube was inserted in the arterial clamp" message when tubing was inside clamp.Perfusionist also mentioned they occasionally would get "init error" message that they would be able to clear out when they would reboot the s5.For safety, the defective erc was replaced with new one.Performed functional check on cp5 with new erc and all testing passed.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 the cp5 rotated and has no forward flow during procedure.There is no report of any patient injury.Through follow up with the perfusionist, livanova learned the error occurred post bypass when the perfusionist was trying to transfuse pump blood volume to cell saver.There was no flow because the erc clamped the line.The cp5 control panel also did not have the erc open/close icon.The perfusionist turned off the s5 and back on and the error messages went away.The displayed error messages were ¿arterial clamp is defective¿ and ¿arterial clamp does not open/close¿.

Manufacturer Narrative

H10: complaints database analysis revealed no similar event since unit installation in 2019.The header of the error message was unknown, however, based on the event description it can be assumed that the error message displayed was "arterial clamp defective".The reported error message can be due to: - hardware failure of the erc (defective zka board, defective zkb board); - mechanical blockage of the spindle; - user error (incorrect tube used by the customer).Based on the above and considering service activity performed by the field service technician, it cannot be ruled out that the reported event was caused by a temporary loss of communication between the erc and the s5 console due to loose/defective components of the erc internal boards.This report was due on november 30, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.

• 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; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17744541
• MDR Text Key: 323388873
• Report Number: 9611109-2023-00434
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)190916
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• 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