MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T (230 VOLT); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 16-02-80

Device Problem Temperature Problem (3022)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in algeria.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, post procedure, a 3t heater cooler displayed error meaning the temperature difference between the control and safety systems is too high (e04).There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: through follow-up communication, livanova learned that the issue affected only cardioplegia side of the device and not the patient one.The cardioplegia solution is delivered in small volumes and at regular intervals allowing the user to perform cooling/heating through alternative methods or to use another circuit of the device.Thus, temperature management on the cardioplegia side is not critical and any malfunction affecting temperature management on the cardioplegia side is considered a non-reportable malfunction.Therefore, the event has been re-assessed as not reportable.

• Brand Name: HEATER COOLER 3T (230 VOLT)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18273489
• MDR Text Key: 329825703
• Report Number: 9611109-2023-00615
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 01/12/2024

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: 16-02-80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2022
• 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