MAUDE Adverse Event Report: ENRICO GRECO HEATER-COOLER SYSTEM 3T; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.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.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication livanova learned that the device was cleaned regularly as per the instruction for use.The device is placed inside the operating theatre during use with the fan opposite to the operating field at an estimated distance of 2-3 meters.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that a heater-cooler system 3t was found to be contaminated with sphingomonas paucimobilis bacterium.Reportedly, the device is cleaned as per the ifu and the water is changed three (3) times per week.There is no known patient involvement.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the customer does not know the serial number of the device involved.The review of the customer installed base allowed to conclude that the serial number of the affected device could be one these (b)(6).Analysis of the complaint database showed that three (3) similar events were reported before and two (2) more cases were reported after this specific event.Based on the investigation of the similar complaints it appears that the customer is operating the device according to the instruction for use.Based on the information collected, the complaint was caused by a source of contamination present at the customer site, despite the precise source of contamination could not be determined.No additional event reported after july 2021 so we can speculate that the source of contamination was later eliminated by the customer.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ENRICO GRECO; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 10545464
• MDR Text Key: 209382547
• Report Number: 9611109-2020-00522
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: LU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/22/2022
• 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