FDA Adverse Event
Malfunction
Summary report: N
LIFECARE PLUM PUMP MODEL 5000
MDR report key: 280122
·
Received May 26, 2000
Report
- Report Number
- 2921482-2000-00095
- Event Type
- Malfunction
- Date Received
- May 26, 2000
- Date of Event
- May 1, 2000
- Report Date
- May 16, 2000
- Manufacturer
- ABBOTT LABORATORIES, INC.
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
OVERDELIVERY REPORTED: THE PUMP WAS PROGRAMMED TO INFUSE LEUCOVORIN AT AN UNSPECIFIED RATE OF DELIVERY TO BE INFUSED OVER 1.5 HOURS. THE TOTAL VOLUME TO BE INFUSED WAS UNSPECIFIED. IT WAS REPORTED THAT THE INFUSION WAS COMPLETE IN 1.0 HOUR. THERE WAS NO PATIENT HARM REPORTED. THE PHYSICIAN WAS NOTIFIED. THERE WERE NO ORDERS OR CHANGE IN THERAPY ORDERED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFECARE PLUM PUMP MODEL 5000 | INFUSION PUMP | FRN | ABBOTT LABORATORIES, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |