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

Model Number 16-02-85

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service technician was dispatched to the customer facility.The error code was not confirmed.However, metal shavings were found inside the unit, possibly caused by a screw touching the stirrer motor.In order to solve the issue, the distribution board and the complete patient bridge were replaced.The unit was tested and put back in service in its expected function.The reported error was most likely caused by the screw touching the stirrer motor compromising its correct rotation.Based on the information available, it cannot be ruled out that an incorrect assembly during previous service activity on the device may have contributed to this fault.

Event Description

Livanova deutschland received a report that a heater-cooler system 3t displayed an error message associated to the stirrer motor during procedure.There was no report of patient injury.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada 80004
• MDR Report Key: 11064962
• MDR Text Key: 223401663
• Report Number: 9611109-2020-00712
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-02-85
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1