FDA Adverse Event
Malfunction
Summary report: N
8100
MDR report key: 2250913
·
Received September 1, 2011
Report
- Report Number
- 2250913
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- May 5, 2011
- Report Date
- September 1, 2011
- Manufacturer
- ALARIS MEDICAL SYSTEMS, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
Narratives
Description of Event or Problem · 1
THE IV PUMP WAS SET TO RUN AT 50 CC/HOUR FOR A 100 CC BAG OF LEUCOVORIN AND INFUSION WAS COMPLETE IN 1 HOUR.
Description of Event or Problem · 1
THE IV PUMP WAS SET TO RUN AT 50 CC/HOUR FOR A 100 CC BAG OF LEUKOVORIN AND INFUSION WAS COMPLETE IN 1 HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8100 | INFUSION PUMP | FRN | ALARIS MEDICAL SYSTEMS, INC. | ALARIS 8100 | 10014205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |