FDA Adverse Event
Malfunction
Summary report: N
PLUM A+
MDR report key: 530399
·
Received March 2, 2004
Report
- Report Number
- 2921482-2004-00121
- Event Type
- Malfunction
- Date Received
- March 2, 2004
- Date of Event
- February 1, 2004
- Report Date
- February 6, 2004
- Manufacturer
- ABBOTT LABS
- Product Code
- FPA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORT REC'D THAT THE DEVICE DID NOT AUDIBLY ALARM BEFORE POWERING OFF. THE PUMP WAS RETURNED TO THE CLINICAL ENGINEERING DEPT WITH A NOTE THAT IT "FAILED TO AUDIBLY ALARM BEFORE SHUTTING OFF." NO TRACKING INFO WAS PROVIDED; THEREFORE, SPECIFIC PT INFO, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM A+ | INFUSION PUMP | FPA | ABBOTT LABS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | PLUM A+ SOFTWARE MODULE, LIST# 12393. |