HEATER COOLER 3T
Report
- Report Number
- 9611109-2023-00585
- Event Type
- Death
- Date Received
- November 2, 2023
- Report Date
- July 30, 2024
- Manufacturer
- LIVANOVA DEUTSCHLAND GMBH
- Product Code
- DWC
- Removal / Correction Number
- Z-2076/2081-2015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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: (B)(6) (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 SURGERIES (2012, 2014 AND 2015), 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.
INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE HEATER-COOLER DISTRIBUTED IN THE AFFECTED COUNTRY IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). 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. 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 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.
D.4 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 WERE DOUBTFUL AND AS A CONSEQUENCE IT IS NOT POSSIBLE TO DETERMINE THE UDI.
SEE INITIAL REPORT.
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. THE COMPLAINANT ALLEGES THROUGH THEIR COUNSEL THAT PATIENT INFECTION. BASED ON THE CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED. THREE OPERATIONS: WYTHENSHAWE ON (B)(6) 2012, LIVERPOOL ON (B)(6) 2014, LIVERPOOL ON (B)(6) 2015.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1928148 | HEATER COOLER 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |