HEATER COOLER 3T
Report
- Report Number
- 9611109-2023-00378
- Event Type
- Death
- Date Received
- August 3, 2023
- Date of Event
- November 15, 2012
- Report Date
- March 4, 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
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A.2-A.5. PATIENT INFORMATION WAS NOT PROVIDED D.4. THE CATALOGUE AND SERIAL NUMBER ARE UNKNOWN. THEREFORE UDI IS UNKNOWN. INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. G.5. THE HEATER-COOLER OBJECT OF THE EVENT 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.
H10: THROUGH FOLLOW UP COMMUNICATION, LIVANOVA 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 SURGERY (2012), WAS UPGRADED WITH VACUUM AND SEALING KIT. 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.
H10: THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT AN ARTICLE RELATED TO THE ISSUE WAS PUBLISHED, ADDING THE FOLLOWING FURTHER INFORMATION. THE AFFECTED PATIENT DIED LAST YEAR AT THE AGE OF 59 AT (B)(6) (BRISTOL), ONLY STARTED SHOWING SYMPTOMS OF THE INFECTION FIVE (5) YEARS AFTER SURGERY, IN THE FORM OF NIGHT SWEATS. ONE OR TWO YEARS LATER, HE WAS DIAGNOSED WITH MYCOBACTERIUM CHIMAERA AND BEGAN TREATMENT FOR THREE (3) YEARS BEFORE DYING IN (B)(6) 2022.
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 OF A MICROBIAL CONTAMINATION. BASED ON THE CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS NOT YET CONFIRMED. OPERATION ON (B)(6) 2012 AT (B)(6).
SEE INITIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1698796 | HEATER COOLER 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND GMBH | UNKNOWN | ||
| 2183557 | HEATER COOLER 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND GMBH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death |