FDA Adverse Event
Malfunction
Summary report: N
PLUM XL MICRO/MACRO PUMP
MDR report key: 530381
·
Received March 2, 2004
Report
- Report Number
- 2921482-2004-00115
- Event Type
- Malfunction
- Date Received
- March 2, 2004
- Date of Event
- February 1, 2004
- Report Date
- February 12, 2004
- Manufacturer
- ABBOTT LABS
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORT REC'D OF THE RATE CONTINUOUSLY SCROLLING WHEN THE CONTROL KNOB IS TURNED TO SET RATE. DURING TESTING AT THE USER FACILITY, WHEN THE CONTROL KNOB WAS PLACED IN THE SET RATE POSITION, THE PUMP WOULD CONTINUOUSLY SCROLL THROUGH THE QUICKSET SEQUENCE. THE PUMP WAS REPAIRED AND PLACED BACK INTO CLINICAL SVC. THERE WERE NO REPORTS OF ANY PT ADVERSE EVENTS WHILE THE PUMP WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM XL MICRO/MACRO PUMP | INFUSION PUMP | FRN | ABBOTT LABS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |