FDA Adverse Event
Malfunction
Summary report: N
PUMP, INFUSION
MDR report key: 17497725
·
Received August 10, 2023
Report
- Report Number
- 17497725
- Event Type
- Malfunction
- Date Received
- August 10, 2023
- Date of Event
- May 15, 2023
- Report Date
- June 29, 2023
- Manufacturer
- ATLANTA BIOMEDICAL CORPORATION
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
FEEDING INFORMATION WAS ENTERED INTO MACHINE AND ENTER WAS SELECTED TO DELIVER THE FEED BUT PLUNGER WAS DISENGAGED. MACHINE DID NOT ALARM THAT PLUNGER WAS NOT ENGAGED AND CONTINUED AS IF FEED WAS BEING DELIVERED. THIS RESULTED IN THE FEED BEING DELAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1758952 | PUMP, INFUSION | FRN | ATLANTA BIOMEDICAL CORPORATION | 80000331 | 69137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 DA | Unknown |