MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T (230 VOLT); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 09/19/2014

Event Type  Injury  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided d.4.Possible sn are (b)(6).H.4.Mfg of the possible sns are: (b)(6) (manufactured 06/apr/04) or (b)(6) (manufactured 31/aug/09) or (b)(6) (manufactured 12/sep/02) or (b)(6) (manufactured 28/jan/08) or (b)(6) (manufactured 27/jun/13) or (b)(6) (manufactured 15/jan/02).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 uk.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.For sn (b)(6 it is not deemed necessary to perform dhr review since contribution of possible native defects can be expected during first usages.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.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 a field action.No device, between the ones possible involved and in use at the hospital at the time of surgeries ((b)(6) 2014), was upgraded with vacuum and sealing kit.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

Livanova deutschland has received a report that, the 3t used during their operation was infected with mc which aerosolised during the operation and came into contact with the patient.The source of mc in 3t has never been determined.Mycobacteria chimera infection acquired post-operatively following a heart valve operation.

• Brand Name: HEATER COOLER 3T (230 VOLT)
• 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: 18844762
• MDR Text Key: 336966502
• Report Number: 9611109-2024-00113
• 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: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/05/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2076/2081-2015
• Patient Sequence Number: 1