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 Difficult to Open or Close (2921)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

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 an electronic remote clamp was not reading retrograde flow during a procedure.There is no report of any patient injury.

Manufacturer Narrative

The livanova service representative in charge was contacted and reported that a replacement erc had been shipped to the customer to remedy the issue and no further issues have been reported after the installation of the new part.A device service history review has been performed and identified that the unit was manufactured in 2021 and no other similar events have been reported.A complaints review was conducted and, according to the results of the analysis, the most likely root causes of the issue are (i) a hardware failure of the erc (e.G.Defective zka board, defective zkb board, defective motor) and/or (ii) fluid ingress inside the housing that may have resulted in a mechanical blockage of the clamp.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.This report was due on (b)(6) 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on (b)(6) 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.

Event Description

See initial 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: 17682121
• MDR Text Key: 322614433
• Report Number: 9611109-2023-00420
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901051
• UDI-Public: (01)04033817901051(11)211202
• 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: 12/04/2023

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: 60-05-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1