FDA Adverse Event
Death
Summary report: N
MS26 SYRINGE DRIVER
MDR report key: 490982
·
Received October 21, 2003
Report
- Report Number
- 9612511-2003-00004
- Event Type
- Death
- Date Received
- October 21, 2003
- Date of Event
- August 2, 2003
- Report Date
- October 21, 2003
- Manufacturer
- GRASEBY MEDICAL LTD.
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INCIDENT REPORTED BY REP. OF HOSP. INFORMED IN 10/2003 BUT STILL TO BE CONFIRMED, PUMP DELIVERING DIAMORPHINE AT A RATE OF 52 - 20ML SYRINGE. UNKNOWN HOW MUCH DRUG WAS OVERINFUSED EXACTLY BUT CUSTOMER QUOTES NOT A GREAT AMOUNT. SPOUSE OF PT NOTICED IT HAD GONE THROUGH TOO QUICKLY. REPORT STATES THAT PT DIED OF NATURAL CAUSES NOT DUE TO THE ALLEGED OVERINFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MS26 SYRINGE DRIVER | SYRINGE DRIVER | FRN | GRASEBY MEDICAL LTD. | MS26 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| O |