FDA Adverse Event
Death
Summary report: N
MS26 SYRINGE DRIVER
MDR report key: 512473
·
Received February 18, 2004
Report
- Report Number
- 9612511-2004-00006
- Event Type
- Death
- Date Received
- February 18, 2004
- Date of Event
- January 24, 2004
- Report Date
- February 10, 2004
- Manufacturer
- GRASEBY MEDICAL LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEVICE ALLEGED TO BE INVOLVED IN A PT DEATH. FURTHER DETAILS RECEIVED IN 02/04 - EBME DEPT AT HOSP TESTED THE DEVICE AND FOUND THAT PUMP WAS RUNNING AT THREE TIMES SET RATE. POLICE HAVE TAKEN THE DEVICE AWAY AND CONTACTED AGENCY FOR FURTHER INSTRUCTIONS. NO FURTHER INFO AVAILABLE AT PRESENT (A QUESTIONNAIRE HAS BEEN SENT TO THE HOSP REQUESTING MORE INFO) - HOSPITAL EBME DEPT WILL RELEASE THEIR TEST RESULTS WHEN AUTHORIZED.
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 |