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

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about an heater cooler showing error message.There is no report of patient injury.

Manufacturer Narrative

H.10: a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue on patient pump.The technician observed that the motor shaft was blocked therefore he replaced the pump and solved the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The reported issue was most likely due to the rust formation on the surface of the balls of the bearing.Possible root causes are water infiltration or water formation due to condensation or high temperatures and high level of humidity in the stationary phase.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 10407330
• MDR Text Key: 204025317
• Report Number: 9611109-2020-00465
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2020
• Patient Sequence Number: 1