FDA Adverse Event
Injury
Summary report: N
HEATER-COOLER SYSTEM 3T
MDR report key: 7099231
·
Received December 8, 2017
Report
- Report Number
- 9611109-2017-00974
- Event Type
- Injury
- Date Received
- December 8, 2017
- Report Date
- December 7, 2017
- Manufacturer
- LIVANOVA DEUTSCHLAND
- Product Code
- DWC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PMA 510(K): THE HEATER-COOLER 16-02-80 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: K052601). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
LIVANOVA (B)(4) RECEIVED A REPORT THAT A PATIENT GOT INFECTED WITH MYCOBACTERIUM CHIMAERA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 879169 | HEATER-COOLER SYSTEM 3T | CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS | DWC | LIVANOVA DEUTSCHLAND | 16-02-80 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| O |