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

Model Number 16-02-85

Device Problems Electrical Shorting (2926); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in cali, colombia.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.Upon internal inspection of device, the cardioplegia cooling coil was found to have a hole causing refrigerant to leak.The device will be replaced with another.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t turned off during start up.There was no patient involvement.

Manufacturer Narrative

H10: through follow-up communication livanova learned that disinfection is done every 15 days using clorox, 180ml per application; exposure time of disinfectant into device is 15 minutes and recirculation of water is carried out in the process.For conservation of the water inside the device, 150ml of hydrogen peroxide is added per application.Storage intervals of this chemical product of are every week.Involved heater cooler 3t system was picked up and replaced with a new one.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: based on all information collected, no instructions for use deviations were identified.It cannot be excluded that the sudden shutdown was traced back to a degradation of the coil leading refrigerant leak.This caused the water to enter the refrigeration cycle and to damage the compressor.Since the device was manufactured in (b)(6) 2021, an isolated case of early degradation due to coil micro-hole formation cannot be ruled out.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15638135
• MDR Text Key: 302085422
• Report Number: 9611109-2022-00532
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: (01)04033817900528(11)210830
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K191402
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1