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

Model Number 16-02-80

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 07/04/2019

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.The incident occurred in (b)(6).A picture has been provided as evidence.Based on the analysis of the provided picture, it is likely that the plastic particle found in the drained water is a piece of one pump head which could have been broken.The customer sent the particle to the livanova service representative in charge in order to compare it with a pump.He provided livanova (b)(4) with a video showing that the particle was perfectly matching the contour of the pump head confirming the initial assumption.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Investigation is ongoing.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 plastic particle was found in the drained water of a heater-cooler system 3t during maintenance.There was no patient involvement.

Manufacturer Narrative

Replaced part was returned to manufacturer for further investigation, it was confirmed that the pump was broken at connection hoe 257.Based on all above facts, the most likely root cause is an unintentional external force that was able to damage the component.

Event Description

See initial report.

Manufacturer Narrative

A livanova field service representative was dispatched to the facility to investigate the device.The device was inspected and it was found that the cardioplegia pump water connection metal fitting was coming away from the plastic moulding.The technician replaced the pump and the issue could be solved.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309
• MDR Report Key: 8855020
• MDR Text Key: 175213187
• Report Number: 9611109-2019-00592
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817901099
• UDI-Public: 010403381790109911160902
• 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,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• 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: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1