FDA Adverse Event
Death
Summary report: N
LEVEL 1 FAST FLOW FLUID WARMER
MDR report key: 1882394
·
Received October 21, 2010
Report
- Report Number
- 2183502-2010-00467
- Event Type
- Death
- Date Received
- October 21, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- KZL
- PMA / PMN Number
- BK860023
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORTER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT, HOWEVER, CURRENTLY, THERE IS NO INFO THAT SUGGESTS THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. AS PER DIRECTION RECEIVED FROM THE FDA ON 12/09/99;
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEL 1 FAST FLOW FLUID WARMER | KZL - DEVICE, WARMING, BLOOD AND PLASMA | KZL | SMITHS MEDICAL ASD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |