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

Model Number UNKNOWN

Device Problem Failure to Pump (1502)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Model and serial numbers are unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the heater-cooler system.The incident occurred in (b)(6).Further information to clarify the reported event has been requested.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 displayed an error code.No detailed information reported however we cannot exclude that this was associated to the stirrer motor on the patient side.There was no patient involvement.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the error code was displayed on patient side.The root cause of the reported event has been traced back to the user who accidentally overfilled the tanks, which led the water to be driven up around the consequently damaged stirrer motor.Based on this, the reportability of the event has been re-evaluated as non reportable since the user error was the only cause of the reported malfunction.

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: 9755082
• MDR Text Key: 196760340
• Report Number: 9611109-2020-00126
• 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: 02/24/2020

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: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 03/23/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1