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

Catalog Number 16-02-85

Device Problem Device Alarm System (1012)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Livanova (b)(4) received a report that, during a procedure, an error was seen in the 3t heater cooled device.The customer did not know which error.Livanova field service was dispatched and could not reproduce the error.There is no report of any patient injury.

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).During follow up with customer, livanova was informed that during heating phase, pump stopped and gave error code.Field service was dispatched and could run the system with no issues.The unit was returned to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: complaints database review revealed that no further complaints have been submitted on this specific unit/issue.Thus, it is reasonable to conclude that the issue did not recur after device was returned back into service following to functional tests which did not detect any device malfunction.Based on available information, it cannot be excluded that the issue was temporary and that it was related to temperature management and control.Indeed, in case of temporary temperature deviation during operation and/or in case of maximum deviations between the patient¿s temperature and the water temperature during heating have been exceeded, the pump of the corresponding circuit stop until temperature stabilises at its set temperature and/or the values for the maximum deviation on the h/c menu are adjusted by the user.Once that temperature stabilises and/or the deviation drops within the normal tolerance range again, the pump can be restarted by the user via the activation button on device keyboard.In this specific case, no adjustment of temperature values from h/c menu was reported by the user, thus it is reasonable to assume that a temporary temperature deviation during operation occurred with consequent expected pump stop and that the pump could be re-activated once the temperature stabilised.However, this is a possible scenario and could not be confirmed.In such situation, the device behaved as expected and did not malfunction as confirmed by troubleshooting findings.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• 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: 13116605
• MDR Text Key: 284694872
• Report Number: 9611109-2021-00751
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 04033817900528
• UDI-Public: 010403381790052811201015
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

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 Catalogue Number: 16-02-85
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1