FDA Adverse Event
Death
Summary report: N
9617604-2006-00057
MDR report key: 789320
·
Received November 27, 2006
Report
- Report Number
- 9617604-2006-00057
- Event Type
- Death
- Date Received
- November 27, 2006
- Product Code
- LGZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
H.6 EVALUATION - OTHER: THE DISPOSABLE WAS DISCARDED AT THE FACILITY. SMITHS MEDICAL ASD, INC IS UNABLE TO PERFORM A THOROUGH INVESTIGATION WITHOUT THE RETURN OF THE ACTUAL SAMPLES INVOLVED. IF INFORMATION IS REC'D OTHER THAN WHAT IS REPORTED; THEN A FOLLOW UP REPORT WILL BE FILED. THE HISTORY OF THIS REPORT REVEALS THAT IT IS PROBABLY DUE TO USER ERROR WHEN LOADING THE HEAT EXCHANGER INTO THE FLUID WARMER. THE INSTRUCTIONS FOR USE SUPPLIED IWTH THIS DEVICE HAS A "WARNING" WHICH IDENTIFIES: "DO NOT BEND HEAT EXCHANGER. BENDING MAY DAMAGE INNER METAL TUBE. SERIOUS PT INJURY COULD RESULT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LGZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |