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

Catalog Number UNKNOWN

Device Problem Contamination (1120)

Patient Problem Bacterial Infection (1735)

Event Date 08/03/2015

Event Type  Injury  

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.

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 a infection m.Chimaera.Surgery date was on (b)(6), 2015 based on the current status of the investigation the alleged device issue was yet not confirmed.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow-up communication livanova learned the device serial number which was used during the surgery.Model/serial numbers have been added to the dedicated d.4 section.Moreover, it was learned that plaintiff alleges that heater-cooler system 3t used during the aortic valve replacement surgery in 2015 was contaminated with mycobacterium chimaera and that device's contamination caused decedent's death.No other information has been made available.Device history record (dhr) of device serial number has been completed and did not identify any deviations or non-conformities relevant to the reported issue.Involved device used at the time of the surgery (2015) was not upgraded with vacuum and sealing kit.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.

• Brand Name: 3T HEATER COOLER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• 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: 17798226
• MDR Text Key: 324029362
• Report Number: 9611109-2023-00463
• 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
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• 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; Death