FDA Adverse Event
Malfunction
Summary report: N
ATLANTA BIOMEDICAL CORPORATION (ABC) INFUSION PUMP
MDR report key: 5382476
·
Received January 21, 2016
Report
- Report Number
- 5382476
- Event Type
- Malfunction
- Date Received
- January 21, 2016
- Date of Event
- October 11, 2015
- Report Date
- December 30, 2015
- Manufacturer
- ELIXIR CORPORATION
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SYRINGE PUMP ALARMED FOR VOLUME DELIVERED. FOUND THE SYRINGE WAS NOT ENGAGED INTO THE PINCH CLAMP AND PUMP WAS RUNNING AS IF DELIVERING THE FEEDING. NO FEEDING WAS DELIVERED. ENTIRE FEEDING WAS LEFT IN THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42535 | ATLANTA BIOMEDICAL CORPORATION (ABC) INFUSION PUMP | PUMP, INFUSION | FRN | ELIXIR CORPORATION | 4100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 YR |