MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number UNKNOWN

Device Problems Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Insufficient Information (4580)

Event Date 07/01/2015

Event Type  Injury  

Event Description

The event was identified through a retrospective review of product liability lawsuits.Through this review, we have identified a few events where the plaintiff had filed a suit against the company, and it was handled by our legal department, but the underlying product information had not been forwarded to the complaint handling unit.Livanova opened a capa to identify any possible lawsuits that might require complaint reporting and to retrospectively submit those events that were not previously submitted and to prevent future similar issues from occurring.Livanova has been notified of a patient infection following a surgery to which he/she underwent on (b)(6) 2015, in which a heater-cooler system 3t was used.Based on current status of the investigation the alleged device issue was yet not confirmed.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.D.4.Serial number is unknown.This information will be provided in a supplemental report if made available.H.4.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.H.9.Livanova deutschland implemented a field safety notice for disinfection and cleaning of heater-cooler devices.The z number is z-2076/2081-2015.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Throught follow up, livanova was informed of the correct hospital name.Relevant fields have been updated.Complaint does not include any information regarding onset of symptoms or if/when m.Chimaera infection was confirmed.Within the information provided it is stated that the patient was seriously injured.Legal lawsuit has been issued and no other information has been made available other than that reported in the complaint file and attached in additional information section.A dhr review could not be performed since possible serial number involved was not provided.Source of patient contamination remains unknown and the livanova device involvement as well.Livanova already implemented a strategy to decrease the probability of bacteria grow in the hc device by applying multiple measures implemented over the past few years through dedicated capa and field action.Involved device serial number remained unknown but was not equipped with vacuum and sealing kit since upgrade activity started in 2017.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 17868883
• MDR Text Key: 324897227
• Report Number: 9611109-2023-00493
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other