FDA Adverse Event
Malfunction
Summary report: N
ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP
MDR report key: 534174
·
Received March 12, 2004
Report
- Report Number
- 2921482-2004-00141
- Event Type
- Malfunction
- Date Received
- March 12, 2004
- Date of Event
- February 1, 2004
- Report Date
- February 18, 2004
- Manufacturer
- ABBOTT LABS
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FROM THE USER FACILITY WITH A COMPLAINT OF A "REAR CASE/LITHIUM BATTERY PROBLEM", WHICH WAS FOUND DURING PREVENTATIVE MAINTENANCE TESTING. DURING INITIAL MFR TESTING, IT WAS FOUND THAT THE MOTOR SHAFT EXTENSION WAS MISSING, WHICH RESULTED IN NONDELIVERY. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT AMBULATORY INFUSION-AIM PLUS PUMP | INFUSION PUMP | FRN | ABBOTT LABS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |