MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ERC TUBING CLAMP / 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-05-65

Device Problem Communication or Transmission Problem (2896)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 erc tubing clamp.The incident occurred in usa.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, during a procedure, the erc shuts off.The erc is not registering with the pump.There was no report of any patient injury.

Manufacturer Narrative

As per information provided from fse on site for pm, the complained unit was re-tested by hospital personnel and the issue was reproduced.The erc was removed from service and scrapped by customer, therefore further testing of the device was not possible.A device service history review has been performed and identified that the unit was manufactured in 2015 and no other similar event has been reported, neither concerning trend has been identified.The specific root cause for the mentioned occurrence is unable to be identified but, considering the results of a similar complaints review and the type of failure, it cannot be ruled out that it is the failure of one of the internal boards, most likely the zka board where the processor, the connector for can connection cable to s5 and the connector to the zkb motor board are present.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to variability of micro subcomponents.However, there is no concerning trend for this kind of failure.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: S5 ERC TUBING CLAMP / 620MM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, 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: 18694623
• MDR Text Key: 335245569
• Report Number: 9611109-2024-00077
• 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: Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-05-65
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2015
• 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