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

Model Number 16-02-85

Device Problem Calibration Problem (2890)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative recalibrated the temperature sensor on the patient tank and the issue could be solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The customer reported that an error code was displayed as soon as patient heating started but the customer did not recall the exact error code.During service activity for this complaint the technician found an error code associated to the stirrer motor (a separated report has been submitted for this issue) and no other error occurred.However, it cannot be confirmed if the error experienced by the customer was due to the stirrer motor or to the temperature sensors issue.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 displayed temperatures on a heater-cooler system 3t were off by about 1.5 degree celsius.There was no report of patient injury.

Manufacturer Narrative

H10: a device service history review has been performed and identified that the unit was manufactured in 2011 and no other similar events have been reported.Based on service activity findings and considering the manufacturing date of involved unit, it cannot be ruled out that reported failure was due to temperature sensor loosing its initial adjustment due to a calibration that reasonably drifted over time.

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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 13768247
• MDR Text Key: 287343116
• Report Number: 9611109-2022-00118
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 03/14/2022

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: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 04/14/2022
• Supplement Dates FDA Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2011
• 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