HEATER-COOLER SYSTEM 3T
Report
- Report Number
- 9611109-2023-00477
- Event Type
- Death
- Date Received
- October 2, 2023
- Date of Event
- August 26, 2014
- Report Date
- August 2, 2024
- Manufacturer
- LIVANOVA DEUTSCHLAND
- Product Code
- DWC
- Removal / Correction Number
- Z-2076/2081-2015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. 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. G.5. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). H.9. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN COVENTRY, UNITED KINGDOM. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
H10: THROUGH FOLLOW UP COMMUNICATION, LIVANOVA LEARNED THAT ALLEGED MALFUNCTION CLAIMED BY THE COMPLAINANT WAS A MYCOBACTERIA CHIMAERA INFECTION ACQUIRED FOLLOWING A HEART VALVE SURGERY IN WHICH A HEATER-COOLER SYSTEM 3T DEVICE WAS USED. IN ADDITION, IT WAS LEARNED THAT POSSIBLE INVOLVED DEVICE SERIAL NUMBERS COULD BE THE FOLLOWING: 16S13260, 16S13261 OR 16S13262 (MODEL: 16-02-80). NO OTHER INFORMATION HAS BEEN MADE AVAILABLE FROM THE CUSTOMER. DEVICE HISTORY RECORDS (DHRS) REVIEW OF POSSIBLE INVOLVED DEVICE SERIAL NUMBERS HAS BEEN COMPLETED AND DID NOT IDENTIFY ANY DEVIATION OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. NO DEVICE BETWEEN THE ONES POSSIBLE INVOLVED AND IN USE AT THE HOSPITAL AT THE TIME OF SURGERY (2014), WAS EQUIPPED WITH VACUUM AND SEALING KIT SINCE UPGRADE ACTIVITY STARTED IN 2017. NO FURTHER INVESTIGATION IS POSSIBLE. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND A DIRECT RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND THE DEVICE COULD NOT BE ESTABLISHED.
D4. THE EVENT IS RELATED TO A LEGAL CASE AND THE INFORMATION FROM CUSTOMER IS REQUIRING THE INVOLVEMENT OF LEGAL DEPARTMENT FROM THE HOSPITAL. FOR THIS CASE THE INFORMATION COLLECTED REGARDING SERIAL NUMBER OF THE DEVICE INVOLVE WAS DOUBTFUL AND AS A CONSEQUENCE IT IS NOT POSSIBLE TO DETERMINE THE UDI.
THE EVENT WAS IDENTIFIED THROUGH A RETROSPECTIVE REVIEW OF PRODUCT LIABILITY LAWSUITS. THROUGH THIS REVIEW, WE HAVE IDENTIFIED A FEW EVENTS WHERE THE PLAINTIFF HAD FILED A SUIT AGAINST THE COMPANY, AND IT WAS HANDLED BY OUR LEGAL DEPARTMENT, BUT THE UNDERLYING PRODUCT INFORMATION HAD NOT BEEN FORWARDED TO THE COMPLAINT HANDLING UNIT. LIVANOVA OPENED A CAPA TO IDENTIFY ANY POSSIBLE LAWSUITS THAT MIGHT REQUIRE COMPLAINT REPORTING AND TO RETROSPECTIVELY SUBMIT THOSE EVENTS THAT WERE NOT PREVIOUSLY SUBMITTED AND TO PREVENT FUTURE SIMILAR ISSUES FROM OCCURRING. COMPLAINANT ALLEGES THROUGH THEIR COUNSEL A BACTERIAL INFECTION FOLLOWING A SURGERY CARRIED OUT ON (B)(6) 2014, IN WHICH A HEATER-COOLER SYSTEM 3T WAS USED. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1836198 | HEATER-COOLER SYSTEM 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND | 16-02-80 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |