HEATER COOLER 3T
Report
- Report Number
- 9611109-2023-00318
- Event Type
- Injury
- Date Received
- July 11, 2023
- Date of Event
- January 30, 2014
- Report Date
- February 29, 2024
- Manufacturer
- LIVANOVA DEUTSCHLAND GMBH
- Product Code
- DWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 SURGERIES (2014 AND 2015), 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.
A.2-A.5. PATIENT INFORMATION WAS NOT PROVIDED 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). D.4. THE SN OF THE MOST LIKELY INVOLVED 3T HEATER COOLER IS (B)(6) THAT WAS MANUFACTURED ON 24/09/2012. THEREFORE, UDI IS NOT APPLICABLE. INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. THE SN OF THE MOST LIKELY INVOLVED 3T HEATER COOLER IS (B)(6) THAT WAS MANUFACTURED ON 24/09/2012. 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 IRELAND. LIVANOVA INITIATED AN INVESTIGATION. THIS EVENT WAS BROUGHT TO LIVANOVA¿S NOTICE BY A LAWSUIT BEING FILED, AND THE POSSIBILITY TO SPEAK WITH THE PERSON SUING US IS LIMITED BY THE RULES OF LITIGATION. HOWEVER, LIVANOVA IS WORKING IN COLLABORATION WITH ITS LEGAL DEPARTMENT TO OBTAIN ANY RELEVANT INFORMATION FROM THE COMPLAINANT. LIVANOVA WILL TIMELY SHARE WITH THE COMPETENT AUTHORITY IN A FOLLOW-UP REPORT ANY RELEVANT ADDITIONAL INFORMATION RECEIVED.
SEE INITIAL REPORT.
COMPLAINANT ALLEGES THROUGH THEIR COUNSEL A BACTERIAL INFECTION. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED. (B)(6) UNDERWENT TWO CARDIAC SURGERIES PERFORMED AT THE (B)(6) ON (B)(6) 2014 AND (B)(6) 2015. (B)(6) ALLEGES THAT A LIVANOVA HEATER/COOLER DEVICE WAS USED DURING BOTH SURGERIES AND THAT IT CAUSED HER TO SUFFER A SERIOUS BACTERIAL INFECTION. (B)(6) ALLEGES THAT THIS INFECTION WAS DIAGNOSED IN (B)(6) 2016. AS A RESULT OF CONTRACTING THIS INFECTION (B)(6) ALLEGES THAT SHE HAS SUFFERED SERIOUS INJURY, INCLUDING PROFOUND DEAFNESS. (B)(6) WAS BORN WITH A CONGENITAL CARDIAC CONDITION KNOWN AS CONGENITAL AORTIC STENOSIS WITH A BICUSPID AORTIC VALVE. IN DECEMBER 2020, LIVANOVA INFORMED THE SOLICITORS THAT UNIT (B)(6) UNDERWENT DEEP INFECTION IN SORIN MUNICH IN JULY 2016 AND COPIED TO THEM LIVANOVA LETTER TO (B)(6) HOSPITAL OF THAT DATE ASKING THAT THE UNIT NOT BE RETURNED FOR DEEP CLEANING PENDING PLAINTIFF'S EXPERT¿S (PROF TAYLOR) INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2147562 | HEATER COOLER 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND GMBH | 16-02-80 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |