FDA Adverse Event
Other
Summary report: N
ABBOTT PLUM A+ INFUSION PUMP
MDR report key: 535117
·
Received March 16, 2004
Report
- Report Number
- 2921482-2004-00151
- Event Type
- Other
- Date Received
- March 16, 2004
- Date of Event
- February 1, 2004
- Report Date
- February 18, 2004
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
REPORT RECEIVED OF AN OVERDELIVERY. THE PUMP WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF HEPARIN AT AN UNSPECIFIED RATE. THE ACTUAL AMOUNT DELIVERED IS UNKNOWN. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF "HUMAN ERROR." THOUGH REQUESTED, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFO.
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. |