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 09/18/2013

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 (b)(4).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.

• Brand Name: HEATER COOLER 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• MDR Report Key: 17798175
• MDR Text Key: 324028424
• Report Number: 1718850-2023-01016
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2018

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 Model Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2018
• Date Report to Manufacturer: 11/17/2018
• Date Manufacturer Received: 11/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other