FDA Adverse Event
Other
Summary report: N
SIGNATURE EDITION INFUSION PUMP
MDR report key: 513501
·
Received February 25, 2004
Report
- Report Number
- 1034172-2004-00001
- Event Type
- Other
- Date Received
- February 25, 2004
- Report Date
- February 24, 2004
- Manufacturer
- ALARIS MEDICAL SYSTEMS, INC.
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER CONTACTED ALARIS AND STATED "THERE WAS AN INCIDENT WITH THE MEDICATION PROFILE WHERE THE PROFILE WAS SET UP WRONG AND THE NURSES DID NOT NOTICE THAT THE PROFILE HAD THE WRONG CONCENTRATION" UPON DISCOVERY THAT AN EVENT HAD OCCURRED THE CUSTOMER CHANGED THE PROFILE AND WAS RELOADING THE PROFILE IN ALL UNITS. UNKNOWN AS 250MG/500CC. UNIT INVOLVED WAS NOT IDENTIFIED, BUT THERE WAS A "BAD OUTCOME'. MULTIPLE MESSAGE LEFT WITH NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGNATURE EDITION INFUSION PUMP | INFUSION PUMP | FRN | ALARIS MEDICAL SYSTEMS, INC. | 7X3X | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |