FDA Adverse Event
Other
Summary report: N
PLUM A+
MDR report key: 414481
·
Received August 30, 2002
Report
- Report Number
- 2921482-2002-00426
- Event Type
- Other
- Date Received
- August 30, 2002
- Date of Event
- August 13, 2002
- Report Date
- August 14, 2002
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FPA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
REPORT RECEIVED OF AN OVER-DELIVERY DUE TO AN ERROR IN PROGRAMMING THE PUMP. AT 1630, A NURSE PROGRAMMED THE PUMP TO DELIVER IVIG AND ATG IN THE MULTISTEP MODE AT AN UNSPECIFIED RATE AND NURSE LEFT THE ROOM. FORTY-FIVE MINUTES LATER, ANOTHER NURSE ENTERED THE ROOM TO INVESTIGATE AN UNSPECIFIED PUMP ALARM. THE SECOND NURSE REPORTED THAT THE PUMP WAS PROGRAMMED INCORRECTLY AND THE PT WAS IN "RIGORS THAT REQUIRED AN UNSPECIFIED DOSE OF DEMEROL". THERE WAS NO REPORTED ADVERSE SEQUELEA. THOUGH REQUESTED, NO FURTHER INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM A+ | INFUSION PUMP | FPA | ABBOTT LABORATORIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention | PLUM A+ SOFTWARE MODULE, LIST#12393,| SERIAL #UNK. |