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

Catalog Number 16-02-80

Device Problem Electrical Shorting (2926)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that the residual current circuit breaker triggers when a heater-cooler system 3t device is switched on.There was no patient involvement.

Manufacturer Narrative

There was no known patient involvement.The heater-cooler (b)(4) 80 is not distributed in the usa, but it is similar to heater-cooler (b)(4) 85, which is distributed in the usa (510(k) number: k191402).H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in koeln, germany.The fault current is triggered by a defective compressor.The device should be discarded and disposed of.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the reported event is a known issue.Livanova put in place corrective action to reduce this type of events in case of breach of the cooling coil being generated due to stirrer flow in the tank leading to hole formation in a narrow area of the coil.However, in this specific case, the exact location of the hole on the cooling coil could not be determined.In october 2019 it was performed the erosion kit upgrade of the device that includes the new design of the pump head of the stirrer motor to prevent the water flow directed to the narrow area of the cooling coil.The reported event was claimed after the upgrade and it is not possible to exclude that the condition of the cooling coil was already compromised before the upgrade to such an extent that the copper was rather degraded.

• Brand Name: HEATER-COOLER SYSTEM 3T
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15101356
• MDR Text Key: 296563855
• Report Number: 9611109-2022-00362
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-02-80
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Date Device Manufactured: 10/17/2014
• 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