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

Catalog Number 16-02-85

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 09/18/2013

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.The complainant alleges through their counsel an infection m.Abscessus 3 years after surgery.Surgery date was on (b)(6), 2013.Based on the current status of the investigation the alleged device issue was yet not confirmed.

Manufacturer Narrative

A.2-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.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 unites states.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 sn of the device in use.Relevant fields have been updated.Livanova received a report that a heater-cooler system 3t device.Patient alleges m.Abscessus infection caused by contaminated 3t used during open heart surgery on (b)(6) 2013.Symptoms arose in or around early november 2015 when patient noticed "boil-like lesion" on sternal incision site, was tested for ntm and staphylococcus infection at that time; ntm came back negative and staph came back positive, so doctors believed issue was due to staph infection though noted also in window of possible m.Abscessus exposure.M.Abscessus infection confirmed in or around (b)(6) 2016.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.Dhr review of device serial number has been completed and did not identify any deviations or non-conformities relevant to the reported issue.Source of patient contamination remains unknown and the livanova device involvement as well.The involved device in use at the hospital at the time of surgery (2013) was not equipped with vacuum and sealing kit since upgrade activity started in 2017.Livanova 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.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: 3T HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, 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: 17798222
• MDR Text Key: 324029354
• Report Number: 9611109-2023-00462
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/03/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 16-02-85
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2018
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2008
• 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