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

Model Number 16-02-80

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported error message.However during evaluation of the device it was found that the float assembly was bent.This issue could be determined as root cause for the incorrect displayed values.The service representative replaced the float assembly to resolve the reported malfunction.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr could not identify any deviations or nonconformities relevant to the 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 a heater-cooler system 3t displayed an error message and it was found that the level indicator was showing incorrect values during the device user maintenance.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

A bent float assembly can lead to two scenarios: either the sensor is stuck on the low position when the tank is full; then the h/c cannot be started as it believes there is no water or the sensor is stuck on the upper position but the tank is empty, water does not flow and an error would be triggered because the motor would not encounter the resistance of the water which was the situation with this complaint.Hence, the floater issue would always be detected prior to use and therefore was retrospectively considered not to be reportable.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8252351
• MDR Text Key: 133360914
• Report Number: 9611109-2019-00035
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-80
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1