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

Model Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 09/10/2013

Event Type  Injury  

Manufacturer Narrative

A.1-a.5.Patient information was not provided.D.4.The catalogue and serial number are unknown.Therefore udi is unknown.Information will be provided in a supplemental report if made available.G.5.The heater-cooler distribtuted in the affected country is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).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 (b)(4).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in united kingdom.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

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.The complainant alleges through their counsel patient infection.Based on the current status of the investigation the alleged device issue was yet not confirmed.Operation on (b)(6) 2013.

Manufacturer Narrative

H10: through follow up communication, livanova learned that alleged malfunction claimed by the complainant was a mycobacteria chimaera infection acquired following a heart valve surgery in which a heater-cooler system 3t device was used.In addition, it was learned that possible involved device serial numbers could be the following: (b)(6), (b)(6), (b)(6), (b)(6), (b)(6) or (b)(6) (model: 16-02-80).No other information has been made available from the customer.Device history records (dhrs) review of possible involved device serial numbers has been completed and did not identify any deviation or non-conformity relevant to the reported issue.No device between the ones possible involved and in use at the hospital at the time of surgery (2013), was equipped with vacuum and sealing kit since upgrade activity started in 2017.No further investigation is possible.Source of patient contamination remains unknown and a direct relationship between the reported adverse event and the device could not be established.

Event Description

See initial report.

• Brand Name: HEATER COOLER 3T
• Type of Device: CONTROLLER, TEMPERATURE, 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: 18108933
• MDR Text Key: 327882856
• Report Number: 9611109-2023-00599
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• 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