FDA Adverse Event
Other
Summary report: N
ABBOTT PLUM A+ INFUSION PUMP
MDR report key: 538521
·
Received March 19, 2004
Report
- Report Number
- 2921482-2004-00156
- Event Type
- Other
- Date Received
- March 19, 2004
- Date of Event
- February 1, 2004
- Report Date
- March 3, 2004
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORT 1 OF 2 RECEIVED OF AN OVERDELIVERY. THE CUSTOMER CONTACT INDICATED THAT THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF XIGRESS AT AN UNSPECIFIED RATE OVER 2 HOURS INSTEAD OF OVER THE INTENDED 12 HOURS. THERE WERE NO REPORTED ADVERSE PT EFFECTS. THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT PLUM A+ INFUSION PUMP | INFUSION PUMP | FRN | ABBOTT LABORATORIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | PLUM A+ SOFTWARE MODULE, LIST #12097. |