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

Model Number 16-02-85

Device Problems Pumping Problem (3016); Noise, Audible (3273)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

There was no known patient involvement.Livanova (b)(4) 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 pump not working.No patient involvement reported.

Manufacturer Narrative

Manufacturing date has been added to the h.4 section.Product problem code and component have been updated due to the previous being incorrect.H.10: videos of the reported fault were shared and analysis revealed that the pump was working but it was noisy.Reportability decision changes to not reportable since the pump was noisy but still functioning.Noise has no impact on functionality and is not likely to result in serious injury.The event is therefore assessed as not reportable.

Event Description

See initial report.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 12376188
• MDR Text Key: 268444345
• Report Number: 9611109-2021-00470
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1